Microcurrent-stimulation-therapy method and apparatus

ABSTRACT

A system and method for applying stimulation therapy to a patient, the system including a first stimulation strip that includes a first elongated portion configured to be placed on the upper eyelid of the first eye of the patient and a second elongated portion configured to be placed on the lower eyelid of the first eye of the patient, wherein the first stimulation strip includes: a first plurality of individually controlled electrodes configured to deliver a microcurrent stimulation therapy to the patient, a first plurality of individually controlled light emitters configured to deliver light stimulation therapy to the patient, and a first plurality of individually controlled heat sources configured to deliver heat therapy to the patient; and a controller operatively coupled to the first stimulation strip and configured to control delivery of the microcurrent stimulation therapy, the light stimulation therapy, and the heat therapy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 17/416,024, filed Jun. 18, 2021 by Marshall T.Masko et al. and titled “Microcurrent-stimulation-therapy apparatus andmethod”, which is a national-phase filing of, and claims prioritybenefit of, PCT Patent Application No. PCT/US2019/067627, filed Dec. 19,2019 by Marshall T. Masko et al. and titled“Microcurrent-stimulation-therapy apparatus and method,” which claimspriority benefit, including under 35 U.S.C. § 119(e), of U.S.Provisional Patent Application 62/783,116 filed Dec. 20, 2018 byMarshall T. Masko, et al., titled “Apparatus and Method for MicrocurrentStimulation Therapy,” each of which is incorporated herein by referencein its entirety.

FIELD OF THE INVENTION

The present invention relates to treatment of a human condition and moreparticularly to a system and method for applying bio-electricmicrocurrent-stimulation therapy, light-stimulation therapy, and/or heattherapy to the human body.

BACKGROUND OF THE INVENTION

Chronic pain is a problem for millions of individuals throughout theworld. One method of treating such pain is to provide microcurrentstimulation around or near the areas where the pain is occurring.Microcurrent, which typically is defined as current below 1 milliamp,can provide rapid and long-lasting pain relief for a wide variety ofpain syndromes. Generally, microcurrent stimulation therapy typicallyincludes applying a current in the range of about 20 to about 300microamps to the affected area. The current blocks neuronal transmissionof pain signals and stimulates the release of endorphins to help relievethe pain in chronic and acute pain patients. Within certain levels ofthis range, the microcurrent mimics the body's own electrical currentlevel and is what we term “bio-electric current.”

In addition to chronic pain relief, microcurrent therapy is being usedto treat a number of visual diseases, including macular degeneration,retinitis pigmentosa, and glaucoma, among other eye diseases. It isbelieved through secondary literature that this microcurrent treatmentstimulates blood flow, increases ATP (adenosine triphosphate) at thecellular level, and enhances cellular permeability. Further, it isbelieved such stimulation can re-establish functional neural pathwaysfor muscle and brain, as well as for blood vessel and brain.

1. Primary Disease for Treatment (AMD)

Age-related Macular degeneration (AMD) is a very common eye disease,affecting more people than glaucoma. Macular degeneration is the mostfrequent cause of blindness for patients aged 60 and above in the UnitedStates, and is estimated to affect over 10 million Americans. (Source:National Health Institute). Macular degeneration results in thedeterioration of various retinal tissues in the region of the macula,the central, most sensitive light-sensing area of the retina responsiblefor detailed central vision. Impaired blood circulation in the centralretina, with partial to full corresponding vision loss, is a typicalconsequence of macular degeneration.

2. Costs of Healthcare and Eye Care

The U.S. spends $2.7 trillion in healthcare each year, of which eye carerepresents roughly three percent or $60-$70 billion of the total.According to Eurostat, the European Union (EU) spends 45.7% of thatamount, or about $1.23 trillion. Expenditures for eye care are growingat six percent annually. According to the National Institutes of Health(NIH), it is expected to continue to grow at least six percent over thenext several decades, driven by the aging population.

Macular degeneration causes about $184 billion in lost productivity eachyear and approximately $51 billion is spent treating maculardegeneration each year in the United States. 90% of macular degenerationcases are the “Dry” or non-bleeding form, termed “Atrophic AMD,” andabout 10% of cases are the “Wet” or bleeding form, termed “ExudativeAMD.”

3. Disease Prevalence

Because there is currently no approved treatment for dry AMD, littleresearch has been done on the market potential. There is, however,significant data on the large numbers of people affected by AMD and isestimated to cause about 8.7% of blindness and low vision globally.According to a report from the World Health Organization, “AMD is theprimary cause of blindness in the developed countries and the thirdleading cause worldwide.” The prevalence of AMD in Europe is estimatedto be: 16.3 million people (excluding southeastern and Eastern Europe),and in the United States 10.2 million people. (Source:www.wrongdiagnosis.com).

Further, this increases to a combined total of 41 million when adding inCanada, Australia/New Zealand, Russia, and Japan. Ninety percent (90%)of these cases are dry AMD for which there is no currently approvedtreatment to restore vision.

Approximately 25% of the population (in the target markets, aged 65 to75 years old) has AMD, and this increases to 35% for ages 75 and older.Within the next 10 to 20 years, as baby boomers reach their mid-sixtiesand older, the prevalence of the disease is projected to dramaticallyincrease. In a study funded by the U.S. Centers for Disease Control andPrevention, researchers reported that as many as 9.1 million people inthe U.S. had AMD in 2010 and 17.8 million would have it by 2020.

4. Causes of AMD

Normal retinal cell function is a photochemical reaction convertinglight energy to an electrical impulse which travels to the brain andvision occurs. With AMD and other visual system diseases, diseased,inflamed retinal cells eventually lose cell function. Adenosinetriphosphate (ATP) levels drop, protein synthesis drops, the electricalresistance goes up, and cell membrane electrical potential goes down.Basically, the cells would appear to go dormant for a time before theydie.

It is believed that when electrical stimulation is provided to the cellsbefore they die, blood vessel permeability is increased, normal cellularelectrical potential is achieved, ATP levels increase, protein synthesiswill occur again, and normal cell metabolism is restored therebyimproving or restoring vision loss. In addition, in vitro studies havedemonstrated that electrical stimulation appears to have a healingeffect on the small blood vessels in the retina, promoting a moreefficient delivery of nutrients to the retinal cells and a moreefficient elimination of metabolic by-products.

The retinal pigment epithelium (RPE) is the support-cell complex for thephotosensitive rod and cone cells which make up the light-sensingretina. The RPE is the first to be affected by circulation impairment.Once affected by poor circulation, the RPE cannot efficiently assist therods and cones in removing the metabolic and photochemical responseby-products, which are common during cellular function.Yellowish-colored sub-retinal deposits called “drusen” form whenextracellular by-products are not carried away by blood circulatingthrough the eye. As a result, the photoreceptor cells in the maculaenter a dormant, toxic state and do not respond to light. If normalretinal cellular metabolism is not restored, the cells die and visualacuity is permanently lost. Thus, it is believed that microcurrentstimulation will help rejuvenate the cells in the retina to slow or stopdegeneration of the eye due to AMD.

5. Potential Treatment/Solution

Clinical studies have demonstrated that with the proper bio-electricmicrocurrent-stimulation waveform and therapy procedure, AMD may beslowed or stopped in a large number of people suffering from thedisease. But, the efficacy of these therapies can be affected by themanual techniques medical professionals use to administer said therapy.Where patients have significant skin impedance, or there is a poorconductivity, uptake of the stimulation level is limited and will limitthe treatment efficacy. This invention, consisting of a headsetappliance of electrodes in a circular, or semi-circular fashion aroundthe eye addresses that problem by communicating, via sensors, with anapparatus that generates bio-electric microcurrent stimulation.

U.S. Pat. No. 10,391,312, issued Aug. 27, 2019 to Blair P. Mowery et al.and titled “APPARATUS AND METHOD FOR OCULAR MICROCURRENT STIMULATIONTHERAPY,” is a U.S national phase of

PCT Application Serial Number PCT/US2016/051550 filed on Sep. 13, 2016with the title “APPARATUS AND METHOD FOR OCULAR MICROCURRENT STIMULATIONTHERAPY” (published as WO 2017/048731), which claims priority to

U.S. Provisional Patent Application 62/283,870 filed on Sep. 15, 2015 byBlair Phillip Mowery et al., titled “Appliance for microstimulationtherapy using a disposable material afixed to the upper and lower eyelid & other body parts,”

U.S. Provisional Patent Application 62/283,871 filed on Sep. 15, 2015 byMarshall T. Masko et al., titled “Apparatus for a method of applicationof microcurrent stimulation therapy, consisting of a goggle deviceaffixed to and encircling the upper and/or lower eyelids, as well asother body parts,” and

U.S. Provisional Patent Application 62/365,838, filed Jul. 22, 2016 byTapp et al., titled “Appliance for micro-current stimulation,” each ofwhich is incorporated herein by reference in its entirety. U.S. Pat. No.10,391,312 describes devices and methods to deliver microcurrentstimulation therapy to the human body, when connected to amicro-stimulation current-generating apparatus. The method of applyingmicrocurrent stimulation therapy to key points around the eye fortreatment of problems such as macular degeneration, retinitispigmentosa, glaucoma, optic neuritis and other eye-related ornerve-related conditions, as well as other diseases, such as Bell'sPalsy, requiring localized stimulation to the eyes and/or on other bodyparts.

U.S. Pat. No. 6,035,236 issued to Jarding, et al. on Mar. 7, 2000 withthe title “Methods and apparatus for electrical microcurrent stimulationtherapy” and is incorporated herein by reference in its entirety. U.S.Pat. No. 6,035,236 describes an apparatus for supplying an electricalsignal to a body part in order to provide microcurrent stimulationtherapy to the body part. The apparatus preferably includes a firstsweep wave or sweep frequency signal generator configured to generate afirst sweep wave signal, a buffer amplifier circuit configured toreceive the first sweep wave signal from the first sweep signalgenerator and amplify and buffer the sweep wave signal creating abuffered sweep wave signal. In addition, the apparatus preferablyincludes a current limiting circuit configured to receive the bufferedsweep wave signal from the buffer amplifier circuit and limit the amountof current supplied to the body part. Finally, the apparatus preferablycomprises a probe for applying the sweep wave signal to the body part.The apparatus may further comprise a second signal generator forgenerating a second signal which may comprise either a sweep wave signalor a non-sweep wave signal. The apparatus also will include a signalcombining circuit configured to receive the first and second signalsfrom the first and second signal generators and combine the first andsecond signals into a composite sweep wave signal.

U.S. Pat. No. 6,275,735 issued to Jarding et al. on Aug. 14, 2001 withthe title “Methods and apparatus for electrical microcurrent stimulationtherapy” and is incorporated herein by reference in its entirety. U.S.Pat. No. 6,275,735 describes a method and apparatus for providingmicrocurrent stimulation therapy to a body part. In one embodiment, amethod allows digital control of the modulation frequency of themicrocurrent signal. The method includes receiving a first digital dataword which is used to produce a first frequency related to the firstdigital data word, whereupon, a first microcurrent signal at the firstfrequency is applied to the body part. A second digital data word isreceived and used to produce a second frequency related to the seconddigital data word. A second microcurrent signal at the second frequencyis applied to the body part. In another embodiment, a method allowsdirect digital synthesis of the microcurrent stimulation signal. A firstdigital data word is used to produce a first analog voltage which isapplied to the body part. A second digital data word is used to producea second analog voltage which is also applied to the body part, wherethe first analog voltage is different from the second analog voltage. Inyet another embodiment, an apparatus for providing microcurrentstimulation therapy includes a digital-to-analog converter, a controllerand a plurality of data words. The controller is coupled to thedigital-to-analog converter and supplies the digital-to-analog converterwith digital data words in order to generate an electrical signal forthe microcurrent stimulation therapy.

U.S. Pat. No. 5,730,720 issued to Sites et al. on Mar. 24, 1998 with thetitle “Perfusion hyperthermia treatment system and method,” and isincorporated herein by reference. U.S. Pat. No. 5,730,720 describes amethod and apparatus to automatically monitor and control a perfusionhyperthermia treatment using a system including one or more programmedcomputers, and mechanical and sensor subsystems. The system includes afluid path between a patient and an external fluid-treatment subsystem,wherein control of the external fluid-treatment subsystem includesfeedback from sensors coupled to the patient. The resulting integratedsystem provides automated monitoring and control of the patient, theexternal fluid-treatment subsystem, and the treatment. In oneembodiment, the fluid passing between the patient and the externalfluid-treatment subsystem is blood. In one embodiment, an apparatus andmethod are provided for using a computerized system for a perfusionhyper/hypothermia treatment of a patient which obtains a body fluidhaving a temperature. A plurality of temperature signals representativeof temperatures at each of a plurality of patient locations on or withinthe patient are coupled to the computer system. Measured temperaturesare compared to a set of stored parameters in the computer system togenerate a comparison value which controls a change in the temperatureof the body fluid. The body fluid is then perfused into the patient toeither warm, cool, or maintain the current temperature of the patient.In one such embodiment, the body fluid is blood withdrawn from thepatient. In another such embodiment, the body fluid is saline.

U.S. Patent Application Publication 2014/0081369 by Sosa, Victor ManuelValencia et al. published on Mar. 20, 2014 with the title“Headache-treatment device with gel dispensing kit and method” and isincorporated herein by reference in its entirety. Patent ApplicationPublication 2014/0081369 describes an electrical-stimulation device withgel-dispensing kit, and a method of making and using the parts of thekit. A convenient and easy-to-use system to provide an electricallyconductive path from a transcutaneous electrical nerve stimulation(TENS) device to the skin surface of a patient to supply transcutaneousstimulation, even through hair. The invention provides improvedprevention and treatment for headache, depression, alertness, attentiondeficit hyperactivity disorder (ADHD), epilepsy, anxiety, post-traumaticstress disorder (PTSD), and behavioral and/or other disorders. Someembodiments provide a headache-treatment system that includes anelectrode base shaped to conform to a back of a human head; a TENShaving projecting spring electrodes each connected to the electrodebase; means for holding an electrically conductive gel in a plurality ofsealed pockets; and means for unsealing the means for holding the geland applying the gel substantially simultaneously to the projectingspring electrodes.

U.S. Patent Application Publication 2017/0300098 by Sen et al. publishedon Oct. 19, 2017 with the title “Supplying power to a computer accessoryfrom a captured WIFI signal” and is incorporated herein by reference inits entirety. Patent Application Publication 2017/0300098 describesexamples of capturing a Wi-Fi signal from a computing devicecorresponding to a computing accessory and harvesting energy from thecaptured Wi-Fi signal. The examples power the computing accessory basedon the harvested energy.

U.S. Patent Application Publication 2008/0028214 by Tafoya et al.published on Jan. 31, 2008 with the title “Secure flash media formedical records” and is incorporated herein by reference in itsentirety. Patent Application Publication 2008/0028214 describes a securemobile device for storing data in a secure manner. The secure mobiledevice has a microarchitecture connected via an interface to flashmemory on the device. The microarchitecture is able to authenticate theaccess of information stored on the secure mobile device using a privatekey. Upon authentication of the access of information, a record owner ofthe device may provide the stored information to third party trustedentities using an associated public key. The secure mobile device allowsfor secure transaction of confidential data on a variety of systems at anumber of locations.

U.S. Patent Application Publication 2010/0049180 by Jonathon D. Wells etal. published on Feb. 25, 2010 with the title “System and method forconditioning animal tissue using laser light” and is incorporated hereinby reference in its entirety. Patent Application Publication2010/0049180 describes systems and methods for prophylactic measuresaimed at improving wound repair. In some embodiments, laser-mediatedpreconditioning would enhance surgical wound healing that was correlatedwith hsp70 expression. Using a pulsed laser (×=1850 nm, T_(p)=2 ms, 50Hz, H=7.64 mJ/cm²) the skin of transgenic mice that contain an hsp70promoter-driven luciferase were preconditioned 12 hours before surgicalincisions were made. Laser protocols were optimized using temperature,blood flow, and hsp70-mediated bioluminescence measurements asbenchmarks. Bioluminescent imaging studies in vivo indicated that anoptimized laser protocol increased hsp70 expression by 15-fold. Underthese conditions, healed areas from incisions that werelaser-preconditioned were two times stronger than those from controlwounds. Our data suggest that these methods can provide effective andimproved tissue-preconditioning protocols and that mild laser-inducedheat shock that correlated with an expression of Hsp70 may be a usefultherapeutic intervention prior to or after surgery.

U.S. Pat. No. 6,385,727 issued to Cassagnol et al. on May 7, 2002 withthe title “Apparatus for providing a secure processing” and isincorporated herein by reference in its entirety. U.S. Pat. No.6,385,727 describes a secure processing environment. In one embodiment,the apparatus includes a read/write memory for storing encryptedinformation. It also includes a processor, a cipherer and anauthenticator. The cipherer is in communication with the read/writememory for receiving encrypted information therefrom and is configuredto decrypt the encrypted information into decrypted information to bereturned to the memory for subsequent use by the processor. Theauthenticator authenticates the decrypted information prior to use bythe processor and re-authenticates the information prior tore-encryption by the cipherer.

U.S. Pat. No. 7,239,910 to Tanner issued on Jul. 3, 2007 with the title“Methods and devices for transcranial magnetic stimulation and corticalcartography,” and is incorporated herein by reference. U.S. Pat. No.7,239,910 describes a method for stimulating and/or inhibiting at leastone point or area of a brain using at least one stimulation device,wherein: the spatial structure of the head or brain is recorded; athree-dimensional simulation model of the surface of the brain isgenerated from the recording of the spatial structure of the brain; andthe stimulation device is arranged relative to the head or brain usingthe three-dimensional simulation model of the surface of the brain, suchthat the at least one point or area of the brain can be stimulated usingthe stimulation device; a device for stimulating and/or inhibiting atleast one point or area of a brain, comprising a recording device fordetecting the spatial structure of the brain, a computational device forgenerating a simulation model of the surface of the brain and at leastone stimulation or induction device, in particular a coil; a method fordetermining the function of a particular area of the brain, wherein atleast one particular area is stimulated using a stimulation device andthe stimulus response is measured at least two different positions, anda device for determining the function of a particular area of the brain,comprising at least one stimulation device and at least two stimulusdetection devices.

U.S. Pat. No. 7,883,536 by Mark P. Bendett et al. issued on Feb. 8, 2011with the title “Hybrid optical-electrical probes” and is incorporatedherein by reference in its entirety. U.S. Pat. No. 7,883,536 describesan optical-signal vestibular-nerve stimulation device and method thatprovides different nerve stimulation signals to a plurality of differentvestibular nerves, including at least some of the three semicircularcanal nerves and the two otolith organ nerves. In some embodiments,balance conditions of the person are sensed by the implanted device, andbased on the sensed balance conditions, varying infrared (IR)nerve-stimulation signals are sent to a plurality of the differentvestibular nerves.

U.S. Pat. No. 8,160,696 by Mark P. Bendett et al. issued on Apr. 17,2012 with the title “Nerve stimulator and method using simultaneouselectrical and optical signals” and is incorporated herein by referencein its entirety. U.S. Pat. No. 8,160,696 describes an apparatus andmethod for stimulating animal tissue (for example to trigger a nerveaction potential (NAP) signal in a human patient) by application of bothelectrical and optical signals for treatment and diagnosis purposes. Theapplication of an electrical signal before or simultaneously to theapplication of a NAP-triggering optical signal allows the use of a loweramount of optical power or energy than would otherwise be needed if anoptical signal alone was used for the same purpose and effectiveness.The application of the electrical signal may precondition the nervetissue such that a lower-power optical signal can be used to trigger thedesired NAP, which otherwise would take a higher-power optical signalwere the electric signal not applied. Some embodiments include animplanted nerve interface having a plurality of closely spacedelectrodes placed transversely and/or longitudinally to the nerve and aplurality of optical emitters.

U.S. Pat. No. 8,996,131 by James M. Owen et al. issued on Apr. 17, 2012with the title “Nerve stimulator and method using simultaneouselectrical and optical signals” and is incorporated herein by referencein its entirety. U.S. Pat. No. 8,996,131 describes a method andapparatus for infrared-light nerve stimulation-plus-therapeutic-heat(INS-plus-TH) that includes providing a plurality of light sources;providing a plurality of thermally conductive extensions configured totransfer heat generated by the plurality of light sources away from theplurality of light sources; emitting a plurality of infrared-lightnerve-stimulation signals toward neural tissue of an animal from theplurality of light sources, wherein the emitted infrared-lightnerve-stimulation signals are configured to generate action potentialsin the neural tissue, and wherein the emitting of the plurality ofinfrared-light nerve-stimulation signals includes generating heat;controlling the emitting of the plurality of infrared-lightnerve-stimulation signals to generate action potentials in the neuraltissue; and transferring the heat generated by the plurality of lightsources during the emitting of the plurality of infrared-lightnerve-stimulation signals away from the plurality of light sources andinto surrounding tissue of the animal using the plurality of thermallyconductive extensions.

A publication titled “Transcranial magnetic stimulation” by Mayo Clinic,www.mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625?p=1(2019) is incorporated herein by reference. This publication describes“Transcranial magnetic stimulation (TMS) is a noninvasive procedure thatuses magnetic fields to stimulate nerve cells in the brain to improvesymptoms of depression. TMS is typically used when other depressiontreatments haven't been effective. This treatment for depressioninvolves delivering repetitive magnetic pulses, so it's calledrepetitive TMS or rTMS. How it works: During an rTMS session, anelectromagnetic coil is placed against your scalp near your forehead.The electromagnet painlessly delivers a magnetic pulse that stimulatesnerve cells in the region of your brain involved in mood control anddepression. It's thought to activate regions of the brain that havedecreased activity in depression. Though the biology of why rTMS worksisn't completely understood, the stimulation appears to impact how thebrain is working, which in turn seems to ease depression symptoms andimprove mood.”

A publication titled “Electrical Stimulation Technologies for WoundHealing” by Luther C. Kloth, Department of Physical Therapy, MarquetteUniversity (Advances in Wound Care, Vol. 3, No. 2, 2014), isincorporated herein by reference. This publication describes “The use ofelectric field (EF) energy applied to chronic wounds to enhance healinghas been used for decades and is based on the existence of endogenouswound EFs that have been observed to direct cell migration after injuryto the integument. The strength of the endogenous wound EFs measured inanimals and humans that have been observed to direct cell migration(electrotaxis) after wounding have been quantified between 10 and 100pA/cm². Research has verified that EF energy enhances the migration oflymphocytes, fibroblasts, macrophages, and keratinocytes. Furthermore,in recalcitrant wounds, it seems likely that the endogenous EFs areaskew or absent, in which case the wounds often do not respond to SWC.When SWC alone fails to heal chronic wounds, electrical stimulation (ES)combined with SWC has been shown in several clinical trials to enhancehealing and closure.” (Footnote numbers removed.)

A publication titled “A practical guide to diagnostic transcranialmagnetic stimulation: Report of an IFCN committee” by Groppa et al. waspublished in final edited form as: Clin. Neurophysiol. 2012 May; 123(5):858-882. doi:10.1016/j.clinph.2012.01.010,(www.ncbi.nlm.nih.gov/pmc/articles/PMC4890546/pdf/nihms787351.pdf) andis incorporated herein by reference. Groppa et al. describes“Transcranial magnetic stimulation (TMS) is an establishedneurophysiological tool to examine the integrity of the fast-conductingcorticomotor pathways in a wide range of diseases associated with motordysfunction. This includes but is not limited to patients with multiplesclerosis, amyotrophic lateral sclerosis, stroke, movement disorders,disorders affecting the spinal cord, facial and other cranial nerves.These guidelines cover practical aspects of TMS in a clinical setting.We first discuss the technical and physiological aspects of TMS that arerelevant for the diagnostic use of TMS. We then lay out the generalprinciples that apply to a standardized clinical examination of thefast-conducting corticomotor pathways with single-pulse TMS. This isfollowed by a detailed description of how to examine corticomotorconduction to the hand, leg, trunk and facial muscles in patients.Additional sections cover safety issues, the triple stimulationtechnique, and neuropediatric aspects of TMS.”

U.S. Pat. No. 10,124,160 issued to Dorvall II et al. on Nov. 13, 2018with the title “Charge steering high density electrode array,” and isincorporated herein by reference. U.S. Pat. No. 10,124,160 describestechnology for deep brain stimulating including devices, systems,computer circuitry, and associated methods foe electrode arrays that areimplanted in the patient's brain. Their deep brain stimulating devicecan include a semiconductor substrate, an array of electrodes coupled tothe semiconductor substrate, and circuitry operable to control the arrayof electrodes. Each electrode can be operable to function as an anode, acathode, a common, or a float independent of other electrodes in thearray to create highly configurable electric fields.

There is a long-felt need for an improved method and apparatus fortherapeutic application of electrical stimulation, optionally along withoptical stimulation, thermal stimulation, and/or pharmaceuticalstimulation, and for collection of data regarding the immediate andlonger-term physiological results of such stimulation, analysis of suchcollected data and adjustment of the controlled parameters to futureapplications of the therapy to a particular patient and tosub-populations of similarly situated patients.

SUMMARY OF THE INVENTION

A system and method for applying stimulation therapy to a patient, thesystem including a first stimulation strip that includes a firstelongated portion configured to be placed on the upper eyelid of thefirst eye of the patient and a second elongated portion configured to beplaced on the lower eyelid of the first eye of the patient, wherein thefirst stimulation strip includes: a first plurality of individuallycontrolled electrodes configured to deliver a microcurrent stimulationtherapy to the patient, a first plurality of individually controlledlight emitters configured to deliver light stimulation therapy to thepatient, and a first plurality of individually controlled heat sourcesconfigured to deliver heat therapy to the patient; and a controlleroperatively coupled to the first stimulation strip and configured tocontrol delivery of the microcurrent stimulation therapy, the lightstimulation therapy, and the heat therapy.

In some embodiments, the present invention provides a microcurrentstimulation apparatus which connects to a micro-stimulation currentgenerating device, wherein the microcurrent stimulation apparatusincludes a headset device encircling the head, and connected toelectrode strips (such as a one-use disposable chip-electrode arrayhaving a unique serial number or crypto code and other functionalitythat is used by the system to look up and deliver customized therapy toa particular patient having their own particular symptoms and medicalhistory), which deliver the stimulation. In some embodiments, theapparatus also either contains a stimulation controller device or isconnected to a separate control device, via either wired or wirelesscommunications. Some embodiments include applying bio-electricmicrocurrent stimulation therapy (optionally along with opticalstimulation, heat stimulation, and/or pharmaceutical therapy) formacular degeneration, retinitis pigmentosa, glaucoma, optic neuritis,Bell's Palsy and other eye diseases to key points around the eye, aswell as other diseases requiring localized and precision stimulation onother body parts. Patient-specific therapy parameters (based on patienthistory, symptoms and past therapy sessions) are passed to the headsetfrom a server, and patient specific data and results are collected tothe server for use in adjusting parameters for future therapy sessionsfor the patient and other patients.

In some embodiments, the bio-electric micro-stimulation apparatus of thepresent invention includes a headset (similar to a crown worn on thehead of the patient), that connects to one or more contact strips eachhaving one or more sets of electrodes in contact with the skin around aperimeter of each eye of the patient, in order to provide stimulationencircling and/or overlapping the outer orbital cavity. The electrodes'contact points deliver the bio-electric microcurrent therapy when theheadset is connected to a bio-electric micro-stimulation controllerdevice (sometimes simply called the “controller”) that controls thegeneration and delivery of such current.

In some embodiments, each contact strip having the treatment electrodesalso contains a micro-chip (i.e., a “chip”) that has electronics and aunique serial number (which is optionally encrypted), or a barcode toauthenticate itself and the contact strip. In some embodiments, eachcontact strip's chip connects with the headset to controlpatient-specific therapy, payment, and usage. In addition, in someembodiments, there is a grounding-electrode component that includes oneor more grounding electrodes. In various embodiments, the headset'selectrodes are controlled by the bio-electric micro-stimulationcontroller device (the “controller”) in one of three ways: (i) thecontroller is built into the headset as a self-contained unit; (ii) thecontroller is in a separate housing (such as a laptop computer or tabletcomputer) that is connected via wires to the headset and/or to theelectrodes on the contact strip; or (iii) the controller is coupled tothe headset via Wi-Fi or Bluetooth®. The Wikipedia entry for “Wi-Fi”indicates: “Wi-Fi is technology for radio wireless local area networkingof devices based on the IEEE 802.11 standards.” The Wikipedia entry for“Bluetooth” indicates: “Bluetooth is a wireless technology standard forexchanging data over short distances (using short-wavelength UHF radiowaves in the ISM band from 2.400 to 2.485 GHz) from fixed and mobiledevices, and building personal area networks (PANs).” In someembodiments, the headset is adjustable to fit various sized heads, or itmay have an open-ended back which does not completely encircle the head(similar to eyeglass temples), so as to fit any sized head.

In some embodiments, the headset also couples via Wi-Fi or Bluetooth® toa server or computer, which recognizes the individual headset viaalgorithmic (encrypted data) codes built into the headset's controlunit. Once the server or computer is connected to the headset andrecognizes the headset's unique algorithmic code, the server or computerenables the headset to provide therapy using patient-specific parameterswhen initiated by a clinician or physician to conduct a treatmentsession. In some embodiments, the server or computer can simultaneouslybill or charge the provider for payment of such treatment session. Insome embodiments, the headset is rechargeable (e.g., via rechargeablebatteries or supercapacitors or other on-headset power source) and isrecharged via a base station or other power supply.

This description of the invention uses the term “bio-electricmicrocurrent” because the microcurrent level selected for the appliedtherapy mirrors the body's own biological electrical current. Hence theterm: “bio-electric current.”

In some embodiments, the headset device of the present invention isreusable (i.e., not a one-use disposable unit), and in others it is aone-time disposable unit. Further, in some embodiments, since theheadset device does not directly touch the treated eye area or otherareas of the patient's skin, there is no need for repeated sterilizationor sanitization to avoid cross-patient eye contamination. In contrast,the skin-contact strip and its electrodes do touch the treated area andare considered to be one-use disposable items. The headset device willbe maintained at a sanitary standard.

In some embodiments, the electrodes of the skin-contact strip, whichconnects to the headset, have a conductive gel (or the like) applied onat least the inner perimeter at the electrode points for properconductivity for stimulation therapy, which generates the prescribedbio-electric microcurrent at an appropriate amplitude, duty cycle,and/or repetition rate or frequency to the appropriate area of the eye,in a timed and dosed temporal sequence to the multiple electrode pointson the electrodes of the skin-contact strip affixed near or to the eyelids. In some embodiments, the electrode points also connect to a sensor(such as an electrical preamplifier and/or analog-to-digital converters,or sensors embedded in the headset or in the outside stimulation device,which will provide feedback to the device to measure for any impedanceof the electrode being driven by the electrical stimulation current, andthe controller and its electronics, based on the sensed current orimpedance, have the ability to automatically adjust the current level tomaintain the initially selected prescribed treatment bio-electriccurrent level. In some embodiments, the electrode(s) being driven withelectrical current at a given time are called “active” and the otherelectrodes that are not being driven with electrical current at a giventime are called “passive.” In some embodiments, sensor electronicsconnected to the “passive” electrodes measure the voltage, stimulationoutput level, wave pattern, frequency, and amplitude, or at variousdistances from the presently driven “active” electrode(s), and thecontroller, based on that measured voltage, stimulation output level,wave pattern, frequency, and amplitude, can adjust the drive signal(s)to the presently driven “active” electrode(s).”

Microcurrent stimulation therapy has begun to be used to treatage-related muscular degeneration (AMD) and other visual systemdiseases; however, the methods and apparatus used in the prior art donot maximize the therapeutic effect and do not provide a way to monitorthe therapeutic delivery and encourage patient compliance with theprescribed treatment regimen. Current devices may not deliver properlyconcentrated stimulation signals at the point where it is appropriatelyneeded. In addition, stimulation levels can encounter impedance, whichblocks or reduces the stimulation level chosen, thereby failing todeliver the appropriate level of stimulation required for propertreatment.

This new invention contains a method to carry and apply an electricalsignal, termed “bio-electric microcurrent,” which is a form ofelectrical stimulation, or “e-stim,” to a specific body part (e.g., theeye) or selected body parts for treatable diseases, to promote or enablehealing of the selected and treated tissue areas. Bio-electricmicrocurrent is a microcurrent range (e.g., in some embodiments, 100 μAto 350 μA) pulsed into the body, which mimics the body's own electriccurrent (e.g., in some embodiments, the microcurrent stimulation rangesfrom 0-1000 micro-Amps). Said apparatus can deliver the appropriatestimulation to specifically targeted selected areas, as well as maintainthe appropriate pressure required to eliminate or minimize patientimpedance, while also continuously monitoring the stimulation leveldelivered to the patient, via a proprietary sensor to ensure it staysconsistent with the level selected by the clinician, regardless ofimpedance or other issues. The invention, which in some embodiments isplaced on the upper and lower eye lids, via the sensor, canautomatically adjust such stimulation to the initial prescribed dosagewhen impedance is detected. The present invention provides this andother solutions to ensure optimum therapy is delivered, during theadministration of treatments for macular degeneration and other eyedisease problems.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention may be derived byreferring to the detailed description and claims when considered inconnection with the figures, wherein like reference numbers refer tosimilar items throughout the figures.

FIG. 1A is a block diagram of a system 101 for delivering stimulationsignals to at least some of a plurality 116 of electrodes connected tothe skin of a patient and for optionally sensing signals from at leastsome of the plurality 116 of electrodes, according to some embodimentsof the present invention.

FIG. 1B is a block diagram of a system 102 for delivering stimulationsignals to at least some of a plurality 116 of electrodes connected tothe skin of a patient and for optionally sensing signals from at leastsome of the plurality 116 of electrodes, according to some embodimentsof the present invention.

FIG. 1C is a diagram of system 103, according to some embodiments of thepresent invention.

FIG. 1D is a cross-section diagram of and electrode-and-gel system 104,according to some embodiments of the present invention.

FIG. 1E is a cross-section diagram of an electrode-and-gel system 105,according to some embodiments of the present invention.

FIG. 1F is a cross-section diagram of an electrode-and-gel system 106,according to some embodiments of the present invention.

FIG. 1G is a block diagram of system 107 having a self-containedcontroller with a stimulation strip 160, according to some embodimentsof the present invention.

FIG. 1H is a block diagram of system 108 having a partially-containedwire-connected controller with a stimulation strip 160, according tosome embodiments of the present invention.

FIG. 1i is a block diagram of system 109 having a partially-containedwireless-connected controller with a stimulation strip 160, according tosome embodiments of the present invention.

FIG. 2A is a schematic diagram of a stimulation system 200 showingdevice 201 in place on the head of a patient 99, according to someembodiments of the present invention.

FIG. 2B is a schematic diagram of a stimulation system 202 showing howthe internal information display 271 of FIG. 2A is visible to the eye 98of patient 99, according to some embodiments of the present invention.

FIG. 2C is a diagram of system 203, according to some embodiments of thepresent invention.

FIG. 2D is a schematic diagram of a stimulation system 204 showingdevice 201 in place on the head of a patient 99, in addition to TCMPG(trans-cranial magnetic pulse generator) 244, according to someembodiments of the present invention.

FIG. 2E is a block diagram of a system 101′ for delivering stimulationsignals to at least some of a plurality 116 of electrodes 1169 connectedto the skin of a patient and for optionally sensing signals fromtemperature sensor(s) and/or pressure sensor(s), according to someembodiments of the present invention.

FIG. 3 is a diagram of system 301, according to some embodiments of thepresent invention.

FIG. 4A is a diagram of system 401, according to some embodiments of thepresent invention.

FIG. 4B is a diagram of system 402, according to some embodiments of thepresent invention.

FIG. 5 is a diagram of system 501, according to some embodiments of thepresent invention.

FIG. 6 is a diagram of goggle-type device 601 having a wireless RFconnection 670 that allows device 601 to connect (e.g., via Wi-Fi) to aseparate device such as a controller in a local laptop, computer server,iPad®, or the like, according to some embodiments of the presentinvention.

FIG. 7A is a diagram of system 701 having a headband tensioner 710 toadjust a pressure of the electrodes against the patient's skin,according to some embodiments of the present invention.

FIG. 7B is a diagram of system 702 having an adjustable-pressure spacer712 to adjust a spacer 711 that applies pressure to the electrodesagainst the patient's skin, according to some embodiments of the presentinvention.

FIG. 8 is a block diagram of system 801 having anadjustable-gel-pressure/vacuum device 810 to adjust a pressure and/orsuction of the gel of the electrodes against the patient's skin,according to some embodiments of the present invention.

FIG. 9A is a block diagram of system 901 having anadjustable-electrical-intensity device 910 to adjust the electricalsignal applied to the electrodes against the patient's skin, accordingto some embodiments of the present invention.

FIG. 9B is a schematic waveform diagram 902 obtained when adjusting theelectrical signal applied to the electrodes against the patient's skin,according to some embodiments of the present invention.

FIG. 10 is a block diagram of system 1000 having anadjustable-spacer-pressure controller 1010 and spacer 1020 to adjust apressure of the electrodes against the patient's skin, according to someembodiments of the present invention.

FIG. 11 is a block diagram of system 1100 having anadjustable-gel-pressure/vacuum device 1110 to adjust a pressure and/orsuction of the gel of the electrodes against the patient's skin,according to some embodiments of the present invention.

FIG. 12 is a block diagram of system 1200 having anadjustable-gel-pressure device 1210 to adjust a pressure of the gel ofthe electrodes against the patient's skin, according to some embodimentsof the present invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

Although the following detailed description contains many specifics forthe purpose of illustration, a person of ordinary skill in the art willappreciate that many variations and alterations to the following detailsare within the scope of the invention. Specific examples are used toillustrate particular embodiments; however, the invention described inthe claims is not intended to be limited to only these examples, butrather includes the full scope of the attached claims. Accordingly, thefollowing preferred embodiments of the invention are set forth withoutany loss of generality to, and without imposing limitations upon theclaimed invention. Further, in the following detailed description of thepreferred embodiments, reference is made to the accompanying drawingsthat form a part hereof, and in which are shown by way of illustrationspecific embodiments in which the invention may be practiced. It isunderstood that other embodiments may be utilized and structural changesmay be made without departing from the scope of the present invention.

It is specifically contemplated that the present invention includesembodiments having combinations and subcombinations of the variousembodiments and features that are individually described herein (i.e.,rather than listing every combinatorial of the elements, thisspecification includes descriptions of representative embodiments andcontemplates embodiments that include some of the features from oneembodiment combined with some of the features of another embodiment,including embodiments that include some of the features from oneembodiment combined with some of the features of embodiments describedin the patents and application publications incorporated by reference inthe present application). Further, some embodiments include fewer thanall the components described as part of any one of the embodimentsdescribed herein.

The leading digit(s) of reference numbers appearing in the Figuresgenerally corresponds to the Figure number in which that component isfirst introduced, such that the same reference number is used throughoutto refer to an identical component which appears in multiple Figures.Signals and connections may be referred to by the same reference numberor label, and the actual meaning will be clear from its use in thecontext of the description.

Certain marks referenced herein may be common-law or registeredtrademarks of third parties affiliated or unaffiliated with theapplicant or the assignee. Use of these marks is for providing anenabling disclosure by way of example and shall not be construed tolimit the scope of the claimed subject matter to material associatedwith such marks.

Overview of the New Technology

Embodiments of the present invention replace the need for manualapplication of the therapy currently used by a clinical professional.The appliance comprises a headset, connecting to a gel-strip orgel-strips containing electrodes and sensors for applying thebio-electric microcurrent therapy to the body part, in this case theeye. The headset's circular inner frame is positioned on the patient'shead for both comfort and ease of treatment application. The headset iswired to either a self-contained controller or wired to connect to aseparate bio-electric microcurrent stimulation device that generates theprescribed bio-electric microcurrent in sequence to the multipleelectrode points on the material strips placed over to totality of theeye, or above and under the eye. The control device to which the headsetinvention is connected also contains a software system that isprogrammed to not only sequence the therapy to the various points on thematerial but also to detect impendence and adjust the level ofbio-electric microcurrent to achieve optimum therapy.

In some embodiments, the present invention could be useful to include ina therapy for treating cancer or other maladies, for example byactivating (or suppressing) chemicals of a chemotherapy or antibodies ofan immunotherapy directed to a particular volume of tissue such as atumor. In some embodiments, the activating (or suppressing) isaccomplished by a combination of one or more of electrical stimulation,light stimulation, thermal stimulation and/or haptic stimulation appliedwith the chemicals of a chemotherapy or antibodies of an immunotherapy.

In some embodiments, the present invention includes an apparatus thatreplaces the need for long-duration manual applications of themicrocurrent/electro stimulation therapy currently used (e.g., such asdescribed in U.S. Pat. No. 6,035,236, which issued to Jarding, et al. onMar. 7, 2000 with the title “Methods and apparatus for electricalmicrocurrent stimulation therapy” and/or U.S. Pat. No. 6,275,735, whichissued to Jarding et al. on Aug. 14, 2001 with the title “Methods andapparatus for electrical microcurrent stimulation therapy”) or beingenvisioned as used by a clinical professional. And, the presentinvention also enables the clinician or physician to deliver stimulationto a particular designated point on the body, as opposed to a broadercoverage or blanketed area of the body. Current conventionaltechnologies have two major drawbacks. First, conventional electricalstimulation delivered with a probe or pointer, is applied manually andtakes a large amount of clinician time to administer and properlydeliver the conventional electrical stimulation. Secondly, whenconventional electrical stimulation gel pads are used in any kind ofelectrostimulation or microcurrent therapy, the gel pads cover anddeliver stimulation across an area affecting a broad part of the humanbody, usually well in excess of 400 square millimeters. This shortcomingof conventional systems prevents the delivery of stimulation to a“pinpointed” area of, for example, 2 to 225 square millimeters (1.4mm*1.4 mm=2 mm² to 15 mm*15 mm=225 mm²), which—in contrast—the presentinvention does allow for, and the present invention can, in certaintreatment therapies, be more efficacious due to a greater electricalstimulation level per unit area delivered on a smaller surface area thatpenetrates more deeply into the underlying tissue, which improvestreatment performance.

FIG. 1A is a block diagram of a system 101 for delivering stimulationsignals to at least some of a plurality 116 of electrodes 1169 connectedto the skin of a patient and for optionally sensing signals from atleast some of the plurality 116 of electrodes 1169, according to someembodiments of the present invention.

As used herein, each generically described “electrode” 1169 includes theelectrical conductor (e.g., in some embodiments, a silver-plated and/orother metal conductor) that is in contact with the patient's skin eitherdirectly or via an interposed electrically conductive gel, as the areaof skin contacted by the electrode and/or gel is limited in lateralextent, e.g., by a pressure-sensitive adhesive 161 (see, e.g., FIG. 1D,FIG. 1E, and/or FIG. 1F).

In some embodiments, system 101 includes a one-use disposablechip-electrode array 110 (which may include one or moreintegrated-circuit chips 111 and/or other circuitry along with an arrayof electrodes 1169 on a flexible and/or elastic substrate 119 such asdescribed in U.S. Pat. No. 10,391,312 issued on Aug. 27, 2019 to BlairP. Mowery et al., titled “Apparatus and method for ocular microcurrentstimulation therapy”), a local microprocessor system 120, and a centralserver 130, wherein chip-electrode array 110 is communicatively coupledto local microprocessor system 120, and local microprocessor system 120is communicatively coupled to central server 130. In some embodiments,chip-electrode array 110 communicates with local microprocessor system120 via a wired connection, and/or by a wireless connection such asBluetooth®, Wi-Fi, infrared light, or the like. In some embodiments,chip-electrode array 110 is powered by a local power source 113 such asa battery, while in other embodiments, power 114 is supplied by a wiredconnection 164 (see FIG. 1C) or, for example, from power captured fromthe Wi-Fi signal such as described in United States Patent ApplicationPublication 2017/0300098 by Sen et al. which published on Oct. 19, 2017with the title “Supplying power to a computer accessory from a capturedWIFI signal”, and which is incorporated herein by reference. In someembodiments, chip-electrode array 110 includes circuitry such as amicroprocessor and signal processor 111 (in some embodiments,microprocessor and signal processor 111 is implemented as a single chipthat is integral; in some other embodiments, the circuitry formicroprocessor and signal processor 111 is implemented by a plurality ofintegrated circuit chips). In some embodiments, the plurality 116 ofelectrodes 1169 are further configured to provide high voltage pulsedcurrent (HVPC) therapy (also referred to as high voltage pulsed directcurrent or high voltage PDC) in a manner such as described by thepublication “Electrical Stimulation Technologies for Wound Healing”(Kloth, Advances in Wound Care, Vol. 3, No. 2, 2014), which isincorporated by reference above. In some embodiments, the plurality 116of electrodes 1169 are further configured to provide low voltage pulsedcurrent (LVPC) therapy (also referred to as low voltage pulsed directcurrent or low voltage PDC) in a manner such as described by thepublication “Electrical Stimulation Technologies for Wound Healing”,which is incorporated by reference above.

In some embodiments, microprocessor and signal processor 111 has anembedded unique serial number (USN) information 158 that uniquelyidentifies each one of the chip-electrode arrays 110 of a plurality ofidentical or similar devices in order that quality control is maintained(e.g., by tracking the manufacturing date, batch, version, and the likeby the serial number (e.g., in some embodiments, in a device database133) to help ensure that the device is fresh (not expired) and hasup-to-date functionality and features suitable for each particularpatient).

In some embodiments, embedded unique serial number information 158further includes public-key encryption information that is used byserver 130 to encrypt data being sent back to chip-electrode array 110,where private-key information needed to decrypt the returned encrypteddata 124 from server 130 remains hidden inside microprocessor and signalprocessor 111 (e.g., in some embodiments, the decryptor is part of dataand software in decryptor/pulse-enable-and-control module 112). In someembodiments, the present invention uses public-key encryptionprivate-key decryption methods and systems such as described in UnitedStates Patent Application Publication 2008/0028214 by Tafoya et al. orU.S. Pat. No. 6,385,727. Such systems allow the destination system (inthis case, the microprocessor and signal processor 111) send out apublic key that any source (in this case, server 130) can use to encryptdata that requires the corresponding private key (which is not publiclyavailable) to correctly descript the date returned from the source.

In some embodiments, the returned data 128 contains medically relevantstimulation-control parameters that are customized (potentiallydifferently) for each particular patient or population of patientshaving a given set of diagnoses and physiological data. In someembodiments, results of each therapy are collected in database 134 andare collectively analyzed to obtain improved future therapy sessions.

By using public-key/private-key communications between themicroprocessor and signal processor 111 and server 130, the returneddata 124 can be checked for validity or modifications after decryptionusing the private key data in microprocessor and signal processor chip111, and the risk of third parties accessing the information, includingpatient's data, is reduced. In some embodiments, local microprocessorsystem 120 also receives a unique patient identifier (UPID) 121associated with the particular patient who is to receive therapy. Insome embodiments, the UPID is associated with the patient but in a senserelatively anonymous until used by the server 130 to associate that UPIDto the patient PII and medical history 122 in server 130. In someembodiments, local microprocessor system 120 appends (or otherwisecombines) the USN 158 and UPID 121, and in some embodiments, encryptsthe result via encryptor-encapsulator-transmission circuit 125 and thentransmits this information to server 130 (e.g., via a cell phoneconnection and/or the internet or the like).

In some embodiments, a separate process 122 is used to input morecomplete patient personal identifying information (PII) and thepatient's medical history that, in some embodiments, is encrypted andstored in patient database (PAT DB) 132. In some embodiments, server 130includes a decryptor/encryptor function 131 that decrypts data fromtransmitted data 129 to locate and retrieve data associated with theparticular patient from patient database 132. In some embodiments, thepatient information itself as stored on PAT DB 132 is encrypted, and sowhen retrieved, the data needs to be decrypted (at least in part) bydecryptor 136.

In various embodiments of the present invention, the functions shown inFIG. 1A and FIG. 1B are implemented as a combination of hardwarecircuitry and software, wherein the some of the various parts of thecombination of hardware circuitry and software are implemented in theone-use disposable chip-electrode array 110, in a stand-alone localmicroprocessor 120 and/or in one or more mobile communications device(s)such as a cell phone, laptop, iPad® or the like. In some embodiments,some or all of local microprocessor system 120 and/or its functiondescribed above is located in a head-worn (goggle-type) apparatus wornby the patient during the procedure. In some embodiments, some or all oflocal microprocessor system 120 and/or its function described above islocated in a bed-side device located near the patient during theprocedure. In some embodiments, some or all of local microprocessorsystem 120 and/or its function described above is located in a cellphone located near the patient during the procedure.

When the USN and UPID information 129 from transmission circuit 125 isreceived by server 130, the PPID information is correlated to theparticular patient to locate and retrieve patient information, historyand treatment parameters from PAT DB 132, which together with USN andUPID information 129 are decrypted by decrypt function 136 and thedevice USN is sent to device and billing database 133.

In some embodiments, device and billing database 133 tracks each deviceserial number and the associated data regarding the particularchip-electrode array 110, such that system 101 can warn if theparticular chip-electrode array 110 has been recalled, is out-of-date(expired due to age), has previously been used (such that re-use of thesingle-use device is contraindicated), is inappropriate for theparticular patient or therapy procedure being requested by the medicalprofessional, or other such problems.

In addition, in some embodiments, device and billing database 133 isused to generate a bill to the patient or their insurance carrier forthe use of that device, wherein the bill can thereby reflect the cost ofthe device as well as the cost of the procedure and other deliverables.The patient information 137 and the device information 139 (e.g., whichincludes, in some embodiments, the number and configuration ofelectrodes 1169, the circuitry and software version, and the like) areused to access the proper therapy parameters 138 from the medicalresults and indication database 134. In some embodiments, those therapyparameters 138 are encrypted (e.g., in some embodiments, using thepublic key information in USN 158 sent from the particularchip-electrode array 110) by encryption function 135 and transmittedback to local microprocessor system 120, wherein in some embodiments,optional decryption function 123 decrypts at least some of theinformation for visual and/or audio presentation on display output unit170 (such as displaying patient name, medical history and the like forreview by the attending medical professional supervising the therapysession so that, for example, that medical professional and/or thepatient can verify the correct therapy is being applied to the correctpatient).

In some embodiments, optional decryption function 123 supplies some orall of the private key information and/or control information 124 neededby circuit 111 to decrypt the control parameters needed for the therapysession. In other embodiments, optional decryption function 123 decryptsonly the patient PII (personal identifying information) and historyinformation displayed on display 170, and for the control information,leaves that portion of the payload of data encrypted for the circuit 111to decrypt and use to control the therapy session. In some embodiments,circuit 111 includes a plurality of transmitter/receivers (that eachtransmit pulsed or otherwise varying micro-current stimulation to anindividual one of electrodes 1169 (wherein a common ground connection isused for the return path of the current) or to a selected pair (or otherplurality) of the electrodes that are chosen/determined in order toapply the current along a chosen path from selected source electrode(s)(one or more of the plurality 116 of electrodes 1169) to selecteddestination electrode(s) (another one or more of the plurality 116 ofelectrodes 1169). In this way, the selected set paths and the selectedsequence of those paths are chosen to target the desired shape and sizeof the volume of tissue to be receiving the therapy.

Once the integrity of the decrypted version of the returned encrypteddata 124 is validated, the payload of the returned data is used tocontrol the transmit portion of transmit/receive (TX/RX) circuitry 115to deliver micro-stimulation signals that are customized for theparticular patient. In some embodiments, the medical indication databaseprovides the initial values for the amplitude, frequency, duty cycle, DCbalance, and/or other parameters for the transmit signal sent fromtransmit/receive (TX/RX) circuitry 115.

In some embodiments, sensed signals 117 from the electrodes 1169 areobtained from the receive portion of transmit/receive (TX/RX) circuitry115 and are processed by process (e.g., feedback-determining) function127 and the pulse-adjust results 118 are used to adjust (e.g., changethe amplitude, frequency, duty cycle, DC balance, and/or otherparameters) the transmit signal sent from transmit/receive (TX/RX)circuitry 115. In some embodiments, the sensed signal is indicative ofthe impedance/resistance seen by a particular electrode or electrodepair. In some embodiments, the sensed signals are from other electrodes(one or more of the plurality 116 of electrodes 1169) not involved inthe transmitted pulse and are indicative of nerve signals or otherphysiological processes.

In some embodiments, information reflecting the sensed signals and thecorresponding stimulation (transmitted) signals on electrodes 1169 isprocessed and encrypted by function 125 and transmitted to server 130 tobe stored in PAT DB 132 to be associated with this patient and thistherapy session. In some embodiments, reported results information 126reflecting information from the patient as to their feeling about thetherapy session and the results obtained from the therapy is processedand encrypted by function 125 and transmitted to server 130 to be storedin PAT DB 132 to be associated with this patient and this therapysession.

In some embodiments, results information and therapy session informationfrom a large plurality of patients is processed and aggregated bysoftware in server 130 or operating on data supplied by server 130 tomodify the medical indications in database 138 such that over time thetherapy for each patient or each type of patient provide improvedparameters for future therapy sessions.

FIG. 1B is a block diagram of a system 102 for delivering stimulationsignals to at least some of a plurality 116 of electrodes 1169 connectedto the skin of a patient and for optionally sensing signals from atleast some of the plurality 116 of electrodes 1169, according to someembodiments of the present invention. In some embodiments, much of thefunctionality of circuit 111 of system 101 has been moved into a localmicroprocessor system 150, leaving only the electrodes 1169 and theirconductor traces on a flexible substrate of one-use disposable electrodearray 140. In some embodiments, a unique serial number (USN) is printedon one-use disposable electrode array 140 or its wrapper, which in someembodiments, is machine readable in the form of a bar code orquick-response (QR)-type symbol 145 or the like. In some embodiments,symbol 148 includes the USN as well as a website identifier that is usedto retrieve a public-key encryption key from an internet site. In someembodiments, the data and software in decryptor/pulse-enable-and-controlmodule 112 functionality that is on chip-electrode array 110 is replacedby data and software in decryptor/pulse-enable-and-control module 152 inlocal microprocessor system 150. In some embodiments,encryptor-encapsulator-transmission circuit 155 includes thefunctionality of encryptor-encapsulator-transmission circuit 125 inaddition to an imager used to capture the image of QR symbol 145 (e.g.,in some embodiments, the camera in a cell phone is used to obtain thedata from symbol 145, and the cell phone provides the functionality, orat least part of the functionality of reference numbers 155, 123, 124,127 and 152). In some embodiments, some of the functionality of localmicroprocessor system 150 (such as decryptor/pulse-enable-and-controlmodule 152, TX/RX 155, and/or display 170) is located on a head-mountedgoggle-type device 201 (such as shown in the diagram in FIG. 1C and FIG.2), and communicates wirelessly to a cell phone that implements theremainder of functions of local microprocessor system 150. The remainderof the functions shown in FIG. 1B are as shown by like reference numbersin FIG. 1A.

FIG. 1C is a diagram of system 103, according to some embodiments of thepresent invention. In some embodiments, system 103 includes thegoggle-type device 201 (which includes headset frame 211 (which hold thefront portion/display frame 221) and temple/ear pieces 214 (which goabove the ears of patient 99)), which, in some embodiments, isconfigured to be placed on the head and connected to the electrodes ofone or more one-use disposable chip-electrode array stimulation strip210 (e.g., an array such as array 110 or array 140 or array 160 or anyother electrode strip described herein) that is placed such that aplurality 116 of electrodes 1169 are over both upper and lower eyelids,or on another body part, along with some of its components (e.g., chip111).

In some such embodiments, electrodes on stimulation strips 210 arecoupled to goggle-type device 201 such that display-screen frame 221 ofdevice 201 covers stimulation strips 210 and help hold stimulationstrips 210 against the skin of patient 99 during use (e.g., as shown byframe 221 and strips 210 in FIG. 2A).

In some embodiments, electrode array stimulation strip 210 furtherincludes one or more light emitters 422 (such as LEDs or the like). Insome embodiments, electrode-array stimulation strip 210 includes uniqueserial-number information 158 that is embedded in one or more integratedcircuit chips 111. In other embodiments, electrode-array stimulationstrip 210 and/or its wrapper (not shown, but similar in concept to abandage cover that keeps the bandage sterile) includes information thatis machine readable, e.g., in the form of an optically readable barcode/UPC code such as quick-response (QR)-type symbol 145 or the like.In some embodiments, system 103 further includes headset frame 211,connector 212 (e.g., in some embodiments, an electrical socket having aplurality of electrical contact points to receive the edge connectorconductors 196 (see, FIG. 1G) of chip-electrode array stimulation strip210) between conductors to the electrodes 1169 and the headset frame211, and electrode skin-contact points 219, numbered from as few as two(2) per electrode array stimulation strip 210 to as many as ten (10) ormore (in some embodiments, as shown in FIG. 1C, there are ten or moreelectrodes 1169 to contact corresponding skin-contact points 219 pereye). In some embodiments, the electrode skin-contact points 219 areeach larger in area than the corresponding electrodes 1169 (such asshown in FIG. 1D, which shows the gel contact area 166 under gel 163being larger than the electrode 1169); in other embodiments, theelectrode skin-contact points 219 are each the same size in area as thecorresponding electrodes 1169 (such as shown in FIG. 1E, which shows thegel contact area 166 under gel 163 being about the same lateral size asthe electrode 1169), and in still other embodiments, the electrodeskin-contact points 219 are each smaller in area than the correspondingelectrodes 1169 (such as shown in FIG. 1F, which shows the gel contactarea 167 under gel 163 being smaller than the electrode 1169). In someembodiments, system 103 further includes side temple piece 214 that goesaround the side of the head (e.g., in some embodiments, to hook over thepatient's ear as do eyeglasses), optional extended lens cover “arm” 215,which, in some embodiments, is used to adjust the contact pressure overthe electrodes of the various contact points 219 around the eye socket,and zero or more optional grounding electrode(s) 216 that, in someembodiments, provides a ground connection between headset frame 211 andthe patient's body. Section line 1D-1D of FIG. 1C shows the location ofthe cross-section of FIG. 1D. In some embodiments, not shown in FIG. 1C,a lens cover arm 215 is located on both sides of headset frame 211. Insome embodiments, one or more ground electrodes 216 is/are included onthe inner surface of the temple pieces 214. In other embodiments, aground electrode conductor 217 is included as a conductor on adisposable film 2171 electrically connected to and covering theskin-contact portions of the temple pieces to touch the patient's skinabove the ear.

FIG. 1D is a cross-section diagram (along section line 1D-1D of FIG. 1C)of an electrode-and-gel system 104, according to some embodiments of thepresent invention. In some embodiments, electrode-and-gel system 104includes one-use disposable electrode array 140 having a skin-facingadhesive 161 on flexible and/or elastic substrate 119, wherein theadhesive 161 and electrically conductive gel 163 are covered by aremovable cover 162. In some embodiments, each of the plurality 116 ofconductive electrodes 1169 is formed (e.g., by printing, plating and/oretching) on a pocket 165 formed in substrate 119, wherein each pocket165 contains a selected amount of electrically conductive gel 163 heldin place by adhesive 161 and cover 162, until the cover 162 is removedso that one-use disposable electrode array 140 can be applied to theskin of the patient with each portion of gel 163 and its electrode beingelectrically isolated from the other electrodes and their gel. In someembodiments, each electrode 1169 is connected to a corresponding one ofa plurality of electrical connectors 164 to send and receive signalsand/or power to and from local microprocessor system 150 (see FIG. 1B).

FIG. 1E is a cross-section diagram of an electrode-and-gel system 105,according to some embodiments of the present invention. In someembodiments, electrode-and-gel system 105 includes one-use disposablechip-electrode array 110 having a skin-facing adhesive 161 on flexibleand/or elastic substrate 119, wherein the adhesive 161 and electricallyconductive gel 163 are covered by a removable cover 162. In someembodiments, each of the plurality 116 of conductive electrodes 1169 isformed (e.g., by printing, plating and/or etching) on pocket 165 formedin substrate 119 (e.g., in some embodiments, by embossing the polymersubstrate 119), wherein each pocket 165 contains a selected amount ofelectrically conductive gel 163 held in place by adhesive 161 and cover162, until the cover 162 is removed so that one-use disposablechip-electrode array 110 can be applied to the skin of the patient witheach portion of gel 163 and its electrode being electrically isolatedfrom the other electrodes and their gel. In some embodiments, eachelectrode 1169 is connected to a corresponding TX/RX 115 of chip 111,and chip 111 communicates information signals 117, 118, 158 and 124 viaa plurality of electrical connectors 164 or, in other embodiments,wirelessly by Bluetooth® or Wi-Fi, to local microprocessor system 120(see FIG. 1A).

FIG. 1F is a cross-section diagram of an electrode-and-gel system 106,according to some embodiments of the present invention. In someembodiments, electrode-and-gel system 106 is substantially similar toelectrode-and-gel system 105, except that electrode skin-contact points219 are each smaller in area than the corresponding electrodes 1169(e.g., in some embodiments, gel contact area 167 under gel 163 issmaller than electrode 1169). In some such embodiments, the lateral sizeof each opening in adhesive layer 161 is made of a desired size to limitthe area of skin contacted by gel 163 to “pinpoint” the electricalcontact to the patient's skin. In some such embodiments, to the area ofa 1.6-mm-diameter circle (i.e., a circular area of about 2 mm²) or asquare that is 1.4-mm on each side (i.e., a square area also of about 2mm²), or other suitable shape and skin-contact area (for example, inother embodiments, areas of 1 mm² (e.g., a square opening in adhesive161 of 1 mm by 1 mm), 3 mm², 4 mm² (e.g., a square opening in adhesive161 of 2 mm by 2 mm), 5 mm², 6 mm² (e.g., a rectangular opening inadhesive 161 of 2 mm by 3 mm), 8 mm² (e.g., a triangular opening inadhesive 161 of 4 mm-wide base by 4 mm height), 9 mm² (e.g., a squareopening in adhesive 161 of 3 mm by 3 mm), 16 mm² (e.g., an opening inadhesive 161 of 4 mm by 4 mm), 20 mm², 25 mm² (e.g., a square opening inadhesive 161 of 5 mm by 5 mm), 36 mm² (e.g., a square opening inadhesive 161 of 6 mm by 6 mm), 49 mm² (e.g., a square opening inadhesive 161 of 7 mm by 7 mm), or other suitable-sized opening). In someother such embodiments, the lateral size of each opening in the bottomof substrate 119 and/or adhesive 161 is made of a desired size to limitthe area of skin contacted by gel 163.

FIG. 1G is a block diagram of system 107 having a self-containedcontroller with a stimulation strip 160, according to some embodimentsof the present invention. In some embodiments, stimulation strip 160 issubstantially similar to chip-electrode array 110 and/or disposableelectrode array 140 except that stimulation strip 160 further includesone or more individually controllable light emitters 180 and, in someembodiments, one or more individually controllable heat sources 190. Insome embodiments, light emitters 180 are configured to providelight-stimulation therapy to the patient (e.g., in some embodiments,combined optical and electrical stimulation to nerves of the patient ina manner such as described in U.S. Pat. No. 7,883,536 titled “Hybridoptical-electrical probes”, U.S. Pat. No. 8,160,696 titled “Nervestimulator and method using simultaneous electrical and opticalsignals”, and/or U.S. Pat. No. 8,996,131 title “Nerve stimulator andmethod using simultaneous electrical and optical signals”, each of whichis incorporated by reference above). In other embodiments, thelight-stimulation therapy includes light pulses to stimulate the retinaoptical receptors in the patient's eye(s). In still other embodiments,an internal display such as internal information/stimulation display 271as shown in FIG. 2A is controlled to provide a light pattern that movesacross the patient's field of view to cause the patient to move theireyes to follow the pattern, in order that the eyes are in differentselected spatial orientations relative to the electrical stimulation sothat different portions of the patient's anatomy in and around the eyesare stimulated more effectively. In some embodiments, internalinformation/stimulation display 271 provides a background color toprovide a relaxing ambiance to patient 99. In some embodiments, internaldisplay 271 also provides information to patient 99 indicating the timeelapsed or remaining duration of the therapy session and/or otherinformation that may be useful (e.g., informative), interesting (e.g.,entertaining), or relaxing (e.g., meditative) to patient 99 (e.g.,graphical or text data).

In some embodiments, heat sources 190 are configured to provide heattherapy to the patient (e.g., in a manner such as described in U.S.Patent Application 2010/0049180 titled “System and method forconditioning animal tissue using laser light”, and/or U.S. Pat. No.8,996,131, both of which are incorporated by reference above). In someembodiments, rather than using laser-induced heating as described inU.S. Patent Application 2010/0049180, the present invention usesresistive heating elements in the stimulation strips 210 and/or goggleapparatus 201 to heat the patient's skin to a temperature of about 42 Cto 43 C (42-43 degrees Celsius (centigrade)) in order to induce thepatient's tissue to generate heat-shock protein 70 (hsp70) near thepatient's eyes to induce a healing response. In some embodiments,stimulation strip 160 is one of two stimulation strips (one for eacheye) and both stimulation strips are coupled to a goggle-type device 201in a manner similar to chip-electrode-array stimulation strips 210 ofFIG. 1C. In some embodiments, stimulation strip 160 is one of twostimulation strips (one for each eye), and the two stimulation stripsare coupled to the eyes of the patient without using a goggle-typedevice 201.

In some embodiments, stimulation strip 160 provides a combination ofmicrostimulation therapy and light-stimulation therapy (in some suchembodiments, each therapy is delivered to the patient simultaneously; inother such embodiments, each therapy is delivered to the patient in asequential manner such that each therapy begins at a different starttime). In some embodiments, stimulation strip 160 provides a combinationof microstimulation therapy, light-stimulation therapy, and heat therapy(in some such embodiments, each therapy is delivered simultaneously withthe other therapies; in other such embodiments, the combination oftherapies is delivered sequentially such that at least two of the threetherapies begin at different start times). In some embodiments,stimulation strip 160 is one of two stimulation strips (one for eacheye), and microcurrent stimulation therapy, light-stimulation therapy,and/or heat therapy is delivered to both eyes simultaneously. In otherembodiments, the one or more therapies (among microcurrent stimulationtherapy, light-stimulation therapy, and heat therapy) delivered to thefirst eye begins at a different start time than the one or moretherapies delivered to the second eye (sequential therapy delivery).

In some embodiments, system 107 includes a controller/power supply 1207that is configured to control delivery of the microcurrent stimulationtherapy, light-stimulation therapy, and/or heat therapy (also referredto collectively as the stimulation therapies). In some embodiments,controller/power supply 1207 is located on the patient (e.g., in agoggle-type device such as device 201, in a device that is placed on(e.g., adhered to) the temple of the patient, or in any other suitablelocation on the patient). In some embodiments, controller/power supply1207 is configured to send control signals 177 to stimulation strip 160and receive feedback signals 178 from stimulation strip 160 via wiredconnections 164 with chip 111.

FIG. 1H is a block diagram of system 108 having a partially-containedwire-connected controller with a stimulation strip 160, according tosome embodiments of the present invention. In some embodiments, system108 includes a controller/power supply 1208 that is configured tocontrol delivery of the microcurrent stimulation therapy,light-stimulation therapy, and/or heat therapy (also referred tocollectively as the stimulation therapies). In some embodiments,controller/power supply 1208 is located separately from the patient(e.g., in a desktop computer or other suitable control device that isnot located on the patient). In some embodiments, controller/powersupply 1208 is configured to transmit control signals 187 to stimulationstrip 160 and receive feedback signals 188 from stimulation strip 160via wired connections carrying signals 187/188.

FIG. 1i is a block diagram of system 109 having a partially-containedwireless-connected controller with a stimulation strip 160, according tosome embodiments of the present invention. In some embodiments, system109 includes a controller/power supply 1209 that is configured tocontrol delivery of the stimulation therapies, and, in some embodiments,controller/power supply 1209 is located separately from the patient andis configured to communicate wirelessly with stimulation strip 160. Insome such embodiments, chip 111 is operatively coupled to atransmit/receive (Tx/Rx) module/power supply 1215 that is configured tocommunicate wirelessly with controller/power supply 1209 (in someembodiments, module 1215 is located on the patient). In someembodiments, controller/power supply 1209 is configured to transmitcontrol signals to stimulation strip 160 and receive feedback signalsfrom stimulation strip 160 via wireless connections 197/188. In someembodiments, controller 1209 is operated via a smart phone 89.

FIG. 2A is a schematic diagram of a stimulation system 200 showingdevice 201 in place on the head of a patient 99, according to someembodiments of the present invention. In some embodiments,display-screen frame 221 includes an internal information and/orstimulation display 271 that can only be seen by patient 99 when device201 is on patient 99, and an external information display 272 thatcannot be seen by patient 99 when device 201 is on patient 99. In someembodiments, external information display 272 is used to displayinformation (e.g., stimulation level (i.e., intensity of stimulation),stimulation type (e.g., light, microcurrent, and/or heat), stimulationtime elapsed and/or time remaining, skin temperature, skin impedancelevel, pressure on the electrodes, and the like) to a medicalprofessional/technician or other person that is assisting/directing thedelivery of the stimulation therapies from device 201 to patient 99. Insome embodiments, internal information and/or stimulation display 271 isused to display information (e.g., stimulation level (i.e., intensity ofstimulation), stimulation type (e.g., light, microcurrent, and/or heat),stimulation time elapsed and/or time remaining, skin temperature, skinimpedance level, pressure on the electrodes, and the like) to thepatient. In some embodiments, internal information and/or stimulationdisplay 271 is used to additionally or instead display visualstimulation to the patient such as one or more points of light that moveacross the patient's visual field to urge the patient to move their eyesto follow the movement of the point(s) of light to orient the eyes indifferent positions during the therapy such that the electric fieldgenerated by the electrodes 1169 stimulate one or more selected volumesof tissue in and/or around the eye. In other embodiments, internalinformation and/or stimulation display 271 is used to additionally orinstead display various colors (such as red wavelengths of 600 nm toabout 700 nmm which might trigger the release of hormones such asmelatonin).

FIG. 2B is a schematic diagram of a stimulation system 202 showing howthe internal information display 271 of FIG. 2A is visible to patient99, according to some embodiments of the present invention. In someembodiments, system 203 includes chip-electrode array strip 210 in placearound an eye 98 of patient 99, where the internal information display271 of display-screen frame 221 is visible to eye 98.

FIG. 2C is a diagram of goggle-type device 203 showing various visualindicators 222 provided by device 201, according to some embodiments ofthe present invention. In some embodiments, device 201 includes a visualscreen 220, incorporated into headset frame 211, indicating a display ofthe various elements of information visible on screen at any one time.In some embodiments, device 201 further includes a display-screen frame221 that includes, for example, two (2) to ten (10) lights 222 on eitheror both sides of the display screen frame 221 (upper plus lower). Insome embodiments, lights 222 are also configured to provide aconfirmation or indication that the contact points of the electrode arefunctioning properly and delivering the appropriate level of currentchosen to stimulate the eye. In some embodiments, display 220 includeslight(s) 223 that indicate which electrode contact point(s) 219 iscurrently active in session, light(s) or display 224 that indicates thelevel of stimulation, and light(s) 225 or display that indicates thestimulation time that has elapsed or the time that remains to completethe present therapy session.

FIG. 2D is a schematic diagram of a stimulation system 204 showingdevice 201 in place on the head of a patient 99, in addition to TCMP(trans-cranial magnetic pulse) generator 244, according to someembodiments of the present invention. In some embodiments, TCMPgenerator 244 is substantially similar to the device described in theMayo Clinic publication titled “Transcranial magnetic stimulation”,which is incorporated by reference above. In some embodiments, thetherapy provided by TCMP generator 244 is referred to as PulsedElectromagnetic Field (PEMF) therapy. In some embodiments, TCMPgenerator 244 uses a device such as described in U.S. Pat. No. 7,239,910titled “Methods and devices for transcranial magnetic stimulation andcortical cartography,” but with the method described therein modified toobtain the spatial structure of one or both of the eyes of patient 99and the surrounding tissue including brain tissue. In some embodiments,a magnetic pulse is generated by TCMP generator 244 to focus the TCMP ona selected region of the eye (in some embodiments, stimulating and/orinhibiting at least one point or area of the eye using at least one TCMPgenerator stimulation device 244, wherein: the spatial structure of thehead or eye is recorded; a three-dimensional simulation model of thestructure of the eye is generated from the recording of the spatialstructure of the eye region; and the TCMP generator stimulation device244 is arranged relative to the head or eye using the three-dimensionalsimulation model of the structure of the eye, such that the at least onepoint or area of the eye can be stimulated using the TCMP generatorstimulation device 244), and is applied either simultaneously with, oralternating with, the adjustable electrical stimulation (and/oradjustable thermal stimulation and/or adjustable pressure/vibrationstimulation) therapy as described elsewhere herein.

FIG. 2E is a block diagram of a system 101′ for delivering stimulationsignals to at least some of a plurality 116 of electrodes 1169 connectedto the skin of a patient and for optionally sensing signals fromtemperature sensor(s) and/or pressure sensor(s), according to someembodiments of the present invention. In some embodiments, system 101′is substantially similar to system 101 of FIG. 1A, but with the additionof additional sensors and/or controllers and actuators to adjusttemperature, pressure (including variable pressure and/or hapticvibration), light, aroma, and the like that can be added to or part ofthe stimulation strip 110′. In some embodiments, a set 176 of one ormore electrical coils 1769 is manufactured on stimulation strip 210(rather than using a separate TCMP generator stimulation device 244 asshown in FIG. 2D), wherein the electrical coils 1769 are driven with anelectrical pulse to generate a TCMP magnetic pulse to the underlyingtissue.

FIG. 3 is a diagram of a goggle-type device 301, according to someembodiments of the present invention. In some embodiments, device 301includes lights on the headset frame (e.g., headset frame 211) to helpthe clinician know the status of treatment. In some embodiments, lightor display 322 indicates if there is stimulation impedance level andwhether that level meets stimulation requirements for a therapy session,and if the stimulation level chosen is being properly delivered; inaddition, some embodiments include ON/OFF lights. In some embodiments,the OFF light 325 activates to indicate that the treatment session hasfinished. In some embodiments, the ON light 326 illuminates when thetreatment session is in process. There may also be individual treatment“session” lights (one per each electrode stimulation point; e.g.,light(s) 223). In some embodiments, the session lights illuminateaccording to the specific treatment point being stimulated at thatparticular moment of the therapy, enabling the clinician to know exactlywhere in the treatment process the patient was.

FIG. 4A is a diagram of a goggle-type device 401, according to someembodiments of the present invention. In some embodiments, device 401includes a light filament 422 (e.g., LEDs, optical fibers, low-powerlaser diodes, or other light source) that is used to provide indicatingand/or soothing ambient light to the patient. In some embodiments, oneor more light filaments 422 is/are located on the interior side of theheadset frame (e.g., headset frame 211) such that light is projectedtoward the patient from light filament 422. A single or a doublefilament line may be used for filament 422. In some embodiments, device401 further includes a vibration “filament”, actuator or buzzer 430 thatis embedded in the headset frame (e.g., headset frame 211).

FIG. 4B is a diagram of a system 402, according to some embodiments ofthe present invention. In some embodiments, the present invention usesone, two or more electrode strips 440 such as one-use disposablechip-electrode array 110 (as described above for FIG. 1A) or one-usedisposable electrode array 140 (as described above for FIG. 1B) orone-use stimulation strip 160 (as described above for FIG. 1G, FIG. 1H,and FIG. 1i ) that are electrically connected to headset 410. In someembodiments, headset 410 is worn by the patient during the therapysession, and includes the functionality as described above for localmicroprocessor system 120 (as described above for FIG. 1A) and/or localmicroprocessor system 150 (as described above for FIG. 1B). In addition,in some embodiments, headset 410 includes one or more LEDs 411 thatprovide flashes or other light signals (for the patient to perceive evenwhen their eyes are closed, and/or the medical professional who isadministering the micro-current electrical stimulation therapy) toindicate that the therapy is working and/or to provide other feedback orinformation to the patient or medical professional. Also, in someembodiments, headset 410 includes one or more haptic vibration devices415 that provide vibration through the frame of headset 410 or by directcontact to the patient's skin (for the patient to perceive even whentheir eyes are closed, and/or via wireless transmission to a wrist-wornfitness monitor, Apple Watch®, Fitbit® or the like such that the medicalprofessional who is administering the micro-current electricalstimulation therapy is notified to look at information displayed ondisplay 272 of frame 221 or other notification) to indicate that thetherapy is working and/or to provide other feedback or information tothe patient or medical professional. In some embodiments, headset 410includes an on-board microprocessor and battery 416 to support thefunctionality for local microprocessor system 120 (as described abovefor FIG. 1A) and/or local microprocessor system 150 (as described abovefor FIG. 1B). In some embodiments, one-use disposable chip-electrodearray 110 (as described above for FIG. 1A) or one-use disposableelectrode array 140 (as described above for FIG. 1B) or one-usestimulation strip 160 (as described above for FIG. 1G, FIG. 1H, and FIG.1i ) further include one or more LEDs 422 to provide an indication offunctionality (e.g., that the electrode array 110 or 140 or 160 isproperly electrically connected to headset 410) and/or an indicationthat therapy is underway. In some embodiments, power for electrode array440 is supplied by a wired power connection 114 among the electricalconductors 164 on a flexible substrate along with the connector thatlead to electrodes 116. In some embodiments, electrode array 110 or 140has an adhesive layer 161 (see FIG. 1D) to hold the electrode array 110or 140 to the patient's skin. In some embodiments, electrode array 110or 140 or 160 is first adhered to the patient in the desired location,then the patient puts on headset 410 and the electrode arrays 110 or 140or 160 are connected to a corresponding jack or other electricalconnection.

FIG. 5 is a diagram of a goggle-type device 501, according to someembodiments of the present invention. In some embodiments, device 501includes a connecting wire 541 that runs from the headset frame (e.g.,headset frame 211) to a bio-electric microcurrent controller device 545(such as a near-by laptop computer, smart cell phone, iPad®, or thelike. In some embodiments, device 501 includes a bio-electricmicrocurrent controller device 550 that is built into the headset frame(e.g., headset frame 211). In some embodiments, device 501 includes asensor 560 on the headset frame (e.g., headset frame 211 or temple sidepieces 214) that provides feedback (such as the sensed impedance of theelectrical connections between the plurality of electrodes 116 and thepatient's skin, or a galvanic skin response of the patient's skin, nerveactivity of areas of the patient's skin near the points of electricalstimulation during electrical stimulation of those nearby points ofelectrical stimulation, nerve activity of the areas at the points ofelectrical stimulation during “rest” time periods between the times ofelectrical stimulation, or the like), to the controller device (e.g.,controller device 545 and/or controller device 550) for use indetermining any needed adjustment in stimulation level being delivered,etc.

FIG. 6 is a diagram of a goggle-type device 601, according to someembodiments of the present invention. In some embodiments, device 601includes a Wi-Fi connection 670 (or other wireless communication meanssuch as infrared signals, RF signals such as Bluetooth® or the like)that allows device 601 to connect, via Wi-Fi (or other wirelessbidirectional or unidirectional communication), to a separate devicesuch as controller device 545, a server, a computer, or the like, inorder to provide separated local or remote access and/or control toand/or for device 601. In some embodiments, device 601 (or other devicessuch as shown and described below for FIG. 7A, FIG. 7B, FIG. 8, FIG. 9A,and elsewhere herein) uses a headband 690 (rather than temple sidepieces 214) to hold the goggle device 601 to the patient's head. In somesuch embodiments, headband 690 further includes other features such asgrounding electrical conductors 216 and/or tensioning devices such asdescribed below.

FIG. 7A is a diagram of system 701 having a headband tensioner 710 toadjust a pressure of the electrodes 1169 against the patient's skin,according to some embodiments of the present invention. In someembodiments, during an initial setup procedure, electrical pulses areapplied to two or more selected ones of the plurality 116 of electrodes1169 and headband tensioner 710 tightens and loosens the tension onheadband 690 in order to achieve a desired impedance or other electricalparameter, and/or to improve patient comfort while maintaining goodelectrical connections to the patient's skin.

FIG. 7B is a diagram of system 702 having an adjustable-pressure spacer712 to adjust a spacer 711 that applies pressure to the electrodesagainst the patient's skin, according to some embodiments of the presentinvention.

FIG. 8 is a block diagram of system 801 having anadjustable-gel-pressure/vacuum device 810 to adjust a pressure and/orsuction of the gel of the electrodes against the patient's skin,according to some embodiments of the present invention.

FIG. 9A is a block diagram of system 901 having anadjustable-electrical-intensity device 910 to adjust the electricalsignal applied to the electrodes against the patient's skin, accordingto some embodiments of the present invention.

FIG. 9B is a schematic waveform diagram 902 obtained when adjusting theelectrical signal applied to the electrodes against the patient's skin,according to some embodiments of the present invention. In someembodiments, an intensity-determination series of pulses 920 aregenerated that have gradually increasing electrical current amplitude(see pulses 921, 922, and 923, etc.), such thatadjustable-electrical-intensity device controller 910 (see FIG. 9A)receives feedback as to the skin impedance and/or patient-generatedfeedback (such as a voice command (or shriek) or a push-button switchsignal) that indicates patient discomfort (see, e.g., pulses 925 and 926that are above the discomfort level 929), and upon receiving suchfeedback signal from the patient or the patient's physiological responseto the pulses), the adjustable-electrical-intensity device controller910 reduces the current and/or voltage of the pulses to a therapeuticlevel 939 that is better tolerated than the level causing discomfort.Then, a therapy series of pulses 930 is applied, e.g., therapy pulses931, 932, 933, etc. The total treatment session 950 includes theintensity-determination series of pulses 920 and the therapy series ofpulses 930.

FIG. 10 is a block diagram of system 1000 having anadjustable-spacer-pressure controller 1010 and spacer 1020 to adjust apressure on stimulation strip 1005 having a plurality 116 of electrodes1169 (see FIG. 1E) against the patient's skin 95 (e.g., in someembodiments, the eyelids of patient 99), according to some embodimentsof the present invention. In some embodiments, system 1000 includes apressure actuator 1020 (a variable-thickness spacer such as a pneumaticchamber, a linear motor, a pair of wedges, or the like) that iscontrolled by pressure controller 1010 to adjust the pressure againstthe patient's skin. In other embodiments (such as shown in FIG. 7A),system 1000 varies a tension applied to a headband 690 to adjust thepressure on the stimulation-strip electrodes. In some embodiments,pressure controller 1010 receives feedback as to the skin impedanceand/or patient-generated feedback (such as a voice command (or shriek)or a push-button switch signal) that indicates patient discomfort (e.g.,the pressure is too high), and upon receiving such feedback signal fromthe patient or the patient's physiological response to the pressure),the pressure controller 1010 reduces the pressure to a therapeutic levelthat is better tolerated than the level causing discomfort. In someembodiments, stimulation strip 1005 includes a plurality of snap-likeprotrusions and/or receivers 1050 (male/female structures) that snaptogether to hold stimulation strip 1005 to corresponding snap-likereceivers and/or protrusions 1022 (female/male structures) on spacer1020 (or goggles 201 as shown in FIG. 11). In some embodiments, eachelectrode 1169 is electrically coupled via conductors 1022 to anelectrical driver circuit (such as 111 of FIG. 1A or 155 of FIG. 1B).

FIG. 11 is a block diagram of system 1100 having anadjustable-gel-pressure/vacuum device 1110 to adjust a pressure and/orsuction of the gel 1163 of the electrodes 1169 against the patient'sskin, according to some embodiments of the present invention. In someembodiments, system 1100 includes a stimulation strip 1105 that includesa plurality of gel-filled channels 1130 that connect to pocket 1165 ofeach electrode 1169 via a channel 1131. In some embodiments, system 1100varies a vacuum (or pressure) applied to the gel 1163 in the pockets1165 by pulling or pushing on the gel (e.g., some embodiment use asyringe operated by a linear motor or the like, the syringepneumatically connected to passageway 1130). In some embodiments, vacuumcontroller 1110 receives feedback as to the skin impedance and/orpatient-generated feedback (such as a voice command (or shriek) or apush-button switch signal) that indicates patient discomfort (e.g., thevacuum is too high) or a less than optimal physiological electrodeconnectivity to the patient, and upon receiving such feedback signalfrom the patient or the patient's physiological response to thepressure/vacuum), the vacuum controller 1110 relaxes the vacuum/pressureapplied to a therapeutic level that is better tolerated than the levelcausing discomfort (or a level that obtains a better physiologicalsignal). In some embodiments, stimulation strip 1105 includes aplurality of snap-like protrusions and/or receivers 1050 (male/femalestructures) that snap together to hold stimulation strip 1105 tocorresponding snap-like receivers and/or protrusions 1122 (female/malestructures) on goggles 201. In some embodiments, each electrode 1169 iselectrically coupled via conductors 1022 to an electrical driver circuit(such as 111 of FIG. 1A or 155 of FIG. 1B). In some embodiments, system1100 can apply a varying vacuum and/or pressure (such as shown in FIG.12) using the same controller 1110.

FIG. 12 is a block diagram of system 1200 having anadjustable-gel-pressure device 1210 to adjust a pressure of the gel ofthe electrodes against the patient's skin, according to some embodimentsof the present invention. System 1200 is substantially similar to system1100 except that controller 1210 only varies the pressure applied to gel1163.

The headset apparatus may contain an LED, LCD, or some other type ofscreen, like a small i-Phone touch screen to show the treatmentsequencing, the status of such treatment, and/or to engage or halt suchtreatment. This screen may show graphics, pictures, or even videofootage related to such treatment process, with the purpose of making iteasier for a clinician to readily assess where the patient is within thetreatment cycle, or to enable the clinician to start, change, or stopsuch treatment cycle. The screen can be a touch screen that enables theclinician to modify the treatment parameters, such as stimulation levelor duration under treatment.

The headset connects via Wi-Fi to server or computer, which recognizesthe individual headset via a unique set of algorithmic codes built intothe headset's control unit. Once the server or computer is connected tothe headset and it recognizes the headset's unique algorithmic code, itcan then enable the headset, when initiated by a clinician or physician,to conduct a treatment session. It can also simultaneously bill orcharge the provider for payment of such treatment session. The headsetcan also send the treatment parameters used to the server or computerfor record of how the device was used. The headset is rechargeable forrepeated use, and it connects to a base station. The base station canplug into the wall to maintain the charge to recharge the headset. Theheadset does not plug into the wall directly for safety purposes.

The apparatus may contain a “light” filament or filaments threadedthrough the headset to convey a low level of light through the patient'sclosed eyes, indicating to the patient, that the appliance/strip isfunctioning as intended. This low level of light will penetrate thepatient's closed eyelid and be received by those photoreceptor cellsfunctioning in the back of the retina. It will resemble a dull flash,and may be either a white light or a specially colored light (such asred or green, like a laser light).

The apparatus may also contain a vibrating filament threaded through theheadset, to convey a light level of vibration as the stimulation isbeing applied. Again, this is for the function of conveying to thepatient that the stimulation is being delivered for those instanceswhere the bio-electric microcurrent, itself, may be simply unfelt by thepatient. The benefit of this is that the patient can feel it working,and will then be more willing to sit and complete the full treatmentsession, versus a session where they have no marker to indicate thatanything is happening.

The application of the apparatus will be performed by the attendingphysician or clinician in the clinic. The patient's eye lids will becleaned with sterile solution contained in a wipe or similar material.The clinician, using sterile surgical gloves, will then open the packetcontaining the headset; the headset will then be mounted on thepatient's head by the clinician. The clinician will then connect theheadset (or goggle)—both forms to be used interchangeably in thefollowing descriptions—to the bio-electric microcurrent strips, and theentire headset will be configured to the patient in the followingmanner:

-   -   The headset will be sized to properly fit the patient in terms        of the size of their head.    -   The headset will be connected to the individual bio-electric        microcurrent strip(s), (electrode)(s) whose contact points will        be placed on the patient's closed eyelids, just below the        eyebrows, across the bone of the upper eye orbit cavity, and        also applied under the eye, along the bone of the lower orbit.    -   The treatment electrode(s) contain an embedded chip to regulate        the performance during treatment, including one-time usage,        identification purposes, and purchase confirmation by clinic or        user.    -   The headset is also connected to one or two grounding electrodes        placed at another point on the body to complete the closed        circuit of the individual bio-electric microcurrent strips.    -   The headset would be connected to the bio-electric microcurrent        device (i.e. controller), built into the headset, or connected        via wire when it is a separate device, or connected via Wi-Fi        when it is a separate device, to initiate therapy.

In some embodiments, when the therapy is finished, a beeper will sound.The clinician will then disconnect the headset from the electrodes, andin the case of a separate control device, from the separate controldevice if it is attached via wires generating the bio-electricmicrocurrent. Next, the clinician will gently remove the headset fromthe patient. The headset will be cleaned in accordance with companyinstructions as guided by any government directives, or in the case of adisposable headset, disposed of in accordance with any governmentdirectives. The patient's eye(s) will be re-cleansed with a sterilewipe/pad.

Advantages of the New Technology

(Microstimulation Headset Frame)

-   -   a. It is an advantage of the present invention to provide a        novel electrode apparatus for providing bio-electric        microcurrent stimulation therapy to a body part to combat        chronic pain, injury, or disease in that body part, or to assess        or monitor internal organ function within the body.    -   b. Another advantage of the present invention is to provide a        novel electrode apparatus for treating various diseases,        including macular degeneration and retinitis pigmentosa.    -   c. Yet another advantage of the present invention is to provide        an electrode apparatus that delivers bio-electric microcurrent        stimulation therapy via a headset frame attached to electrodes        that are wired to (or connected via Wi-Fi to) the control        apparatus and are positioned on the upper or lower eye lid with        an adhesive material.    -   d. Yet another advantage of the headset is that the clinician        can begin treatment and leave the patient during the treatment        cycle for multi-tasking efficiency and reducing clinician labor.    -   e. Yet another advantage is that the clinician can be away from        the patient, but periodically check on the patient's progress        with the headset's screen.    -   f. Yet another advantage of the headset/goggle device, with the        connected electrodes, is the automation of the treatment process        and its ability to deliver a consistent treatment, thereby        minimizing variability of such treatment that otherwise would be        present if it were delivered manually by a clinician in terms        of: time, pressure of the electrode at the point of stimulation,        consistency of application, contact of the electrode, and        consistency of the stimulation level being delivered as        initially selected for treatment setup.    -   g. Yet another advantage is that both eyes are set up        simultaneously for treatment, saving time since there is just        one set up. (The patient may have one eye treated at a time and        then the other, during the treatment cycle, OR the headset could        be configured to simultaneously treat both eyes at once, one        electrode point at a time per each eye until the cycle is        completed.)    -   h. Yet another advantage of the headset's inner circular frame        is that it will comfortably and easily fit most patients' heads        and make for easy connection of the electrodes around the eye.    -   i. This headset contains or will be connected to various numbers        of electrodes or sensors, which are wired and sensed        individually by a controller device, which gives the ability of        the apparatus to monitor the current supplied to the various        contact points in the electrodes, and to adjust the current        based upon the degree of impedance.    -   j. The invention will be packaged as sanitary, depending upon        the requirements in a barrier-proof package.    -   k. Yet another advantage is this headset apparatus will be        connected to a software program that can administer the        treatment therapy, and can also collect patient information        regarding the application of the treatment applied to the        patient, for improved patient outcomes.    -   l. Yet another advantage is that the invention contains one or a        number of light filaments in the headset frame, that can signal        the patient that the proper level of therapy is being delivered        to the patient and that they are not experiencing undue        impedance.    -   m. Yet another advantage is in the field of safety, as the        device cannot be randomly used since it needs to be        pre-authorized by the server or computer, via the unique        algorithm, to conduct the treatment session.    -   n. Yet another advantage is that the payment for each treatment        is monitored on an individual basis by the server or computer,        with each session used being specifically enabled by the        server/computer, tracked, and accounted for, so it can be paid        for by the clinic.    -   o. Yet another advantage is that the clinician can see the        status of the therapy in session and or modify it at any time,        with the use of the headset's touch screen.    -   p. Yet another advantage is the headset plugs into a base        station device that recharges the headset, so that the headset        can be recharged and used repeatedly, and so that the headset        does not directly plug into the wall, which is a usage safety        guard for the patient per regulatory codes.    -   q. Yet another advantage is that the treatment electrodes        contain a chip, similar to a security chip in a credit card but        optionally with additional functionality such as a controller        and current drivers and receiving preamplifiers and the like,        which enables a one-time use and can be tracked via the headset        controller. This prevents the reuse of electrodes for a safety        and hygiene basis, as well as insures proper accounting for the        electrodes from a purchase and billing standpoint. This chip        technology will enable confirmation of: electrode identity and        authenticity, purchase, and one-time usage.    -   r. Accordingly, it is an advantage of the present invention to        incorporate a safety element by individually wiring each        electrode sensor point connected to the treatment device, which        provides the bio-electric stimulation. Such design prevents more        than one electrode point delivering the therapy simultaneously,        unless so specifically programmed, and potentially injuring the        patient.    -   s. The advantage of this apparatus is that the bio-electric        stimulation is not carried simultaneously over the entire        surface of the treated area, and that an individually targeted        area of the eye can be treated with stimulation therapy, while        not stimulating other areas of the eye or surrounding tissues.        Stimulation is delivered at differing specific individual points        in a programmed manner, versus the current standard of a general        stimulation delivery over the affected area in the many other        medical fields where electrode stimulation is used.    -   t. The advantage of highly targeted bio-electric stimulation is        that this ensures that a more concentrated delivery is made to        the targeted area, with a greater chance of deeper inner        penetration of the stimulation, to the back of the retinal        tissues, where it can do the most good to reactivate cellular        activity, and avoiding higher levels of stimulation, which might        otherwise be required without such targeting, which can        incidentally cause damage to the more sensitive tissues.    -   u. Another advantage is that specific areas of bio-electric        stimulation can be chosen by the physician, as determined by the        program used in the bio-electric microcurrent device connected        to the headset/apparatus. It has specifically sequenced points        within the electrodes that can deliver timed specific        stimulation to different points along the frame itself, in a        pre-set sequence, for a varied or pre-set time, at an individual        point of contact, or at two or more points of individual        contact, with preset stimulation levels, as opposed to a single        Gel Pad which offers blanket stimulation over the entire surface        area of the pad.    -   v. Another advantage of this appliance and its treatment        methodology is that it enables the physician to target        bio-electric stimulation to a particular treatment point (as        small as 2 millimeters, or as large as 15 millimeters), which        improves treatment efficacy since a higher current dose cannot        be tolerated by the body at a small pinpoint of delivery, or be        effective if delivered over a larger surface area, such as by a        standard gel pad. Further, this bio-electric stimulation can be        delivered to a specifically designed and tolerated treatment        point within a timed sequence and then on to another in a        pre-set pattern designed to optimize treatment results for        patients.

Elements of Apparatus Design According to Some Embodiments:

-   -   a) Method for Application to upper, and/or lower eye, as well as        other body parts.    -   b) Bio-electric Microcurrent Headset Frame.    -   c) Headset Frame connects to electrodes, which stimulate the        upper and lower eyelid, or other body part(s) as applied, using        an electrode with a gel coating.        -   a. Such electrodes contain a chip and this technology serves            to identify the electrode using this chip to the controller            as authentic, to allow a one-time use for safety and hygiene            purposes, and to ensure payment regulation.    -   d) Headset frame connects to electrodes which:        -   1. Have between 1-10 (or more) contact points on the top of            the strip for the top closed eye lid or skin covering the            upper orbit.        -   2. Have between 1-10 (or more) contact points on the bottom            of the strip for the bottom closed eye lid or skin covering            the lower orbit.        -   3. Do not stimulate entire eye, only under those specific            points selected within the stimulation program determined by            physician and programmed into device.        -   4. Contact points can be individual or multiple, meaning            that ONE contact point can stimulate at a time per eye, or            body part; OR two to several contact points may stimulate            simultaneously, determined by the program selected on the            device. (In addition, the entirety of the strip(s), and all            of the contact points may also be active with stimulation at            any one given point during the treatment in addition to the            individual points stimulated.)        -   5. Contact points may stimulate individually or in multiple            points, in a pre-programmed sequence, with a pattern that is            pre-set in terms of specific stimulation level(s),            individual stimulation point duration time(s), total program            run time, number of times of stimulation per eye point,            etc., all of which is determined by the program in the            device, selected by the attending clinician delivering the            stimulation.        -   6. Contact points are capable of receiving varied            stimulation levels as determined by device. (Meaning that            the stimulation level delivered through the various contact            points can vary and be increased or decreased throughout the            course of the treatment program selected.)    -   e) This invention makes it is less labor intensive to conduct        the treatment (since the clinician can turn the headset on,        start the programmed treatment, and go off to do another task        while the program runs its course); less time consuming (since        the clinician is freed up during the programs duration to attend        to other tasks), and less fatiguing (since the clinician does        not need to stand over the patient and hold the stimulation        probe.)    -   f) Safety Element: The headset and its controller (whether built        in or attached via wires) rely on a safety governor built in to        the controller device, so one point cannot deliver more than,        for example, 1000 microamps of current. Sensors: Headset,        controller, and strips have a built-in sensor to monitor        stimulation level delivered to improve treatment performance:        -   1. Sensor also gauges impedance of skin:        -   2. Sensor to give feedback to device to actual stimulation            delivered to skin. (Feedback loop)        -   3. Sensor to automatically adjust bio-electric current level            deliver to patient, to achieve the selected/programmed            stimulation level, regardless of impedance. (in some            embodiments, up to 1000 microamps)    -   g) Headset may contain an internal light filament built in to        frame to indicate stimulation delivery to patient. Filament        would flash lightly in conjunction with the delivery of the        stimulation. This feature can be manually turned off for no        flash.    -   h) Headset may contain an external visible light for the        clinician to monitor treatment. Light will go from constant        (when selected stimulation is appropriately delivered); to flash        if stimulation being delivered has impedance and is        under-delivered; or, to rapid flash if impedance is high and        stimulation being delivered is significantly under-delivered.    -   i) Headset may contain a vibration element built into frame,        designed to indicate stimulation delivery.    -   j) Headset either has a built-in controller or contains a        connection element to primary controller device, via either        wires or via Wi-Fi.        -   1. The controller has a unique algorithm ensuring its            identification and connection to the server or computer.        -   2. Each controller can be identified as to location and            modified by the company as to its operational capabilities,            permitting the company to upgrade the controller software            and operating system at any time.        -   3. The controller requires the connection to the server or            computer for activation of the therapy to ensure control            over the therapy sessions being delivered and to ensure            proper payment for such sessions.    -   k) Headset has a built-in touch screen (in some embodiments,        smaller, but similar to an Apple iPhone®). This touch screen        enables the clinician to start the program; to stop the program;        and to adjust any of the treatment variables. It also features a        display with a read-out of the treatment status in progress.    -   l) Headset may have two moveable or “flip-oriented” lens covers,        (one around each eye), that are lens-less, but designed to come        in moderately tight contact, (e.g., in some embodiments, a range        of two ounces per square inch (about 862 Pascals) to        fifteen (15) pounds per square inch (about 0.103 megapascals)),        with the closed upper and lower eye lid, to ensure proper        contact with the electrode. This could be done via a spring        mounted to the lens cover arm, as it is flipped down to cover        the electrode strip(s), or any other suitable apparatus for        applying pressure to the lens cover arm.    -   m) The headset design can be adjusted to accommodate different        sized anatomical head configurations.    -   n) Headset may contain a sensor for feedback to device to        register stimulation level being delivered.    -   o) Headset may contain a timing sensor (buzzer/chime) to notify        when session is completed.    -   p) Headset may contain an LED or LCD type of screen, in some        embodiments, similar to a small iPod® screen, showing the status        of the treatment session, including which eye is being        stimulated, which eye point is being stimulated, where in the        cycle of stimulation the treatment session is, and when the        session has ended. This visual screen will also show product        name, program time elapsed, and stimulation level being        delivered to patient.

In some embodiments, the present invention provides an apparatus forapplying bio-electric microcurrent stimulation therapy to the humanbody, via a disposable chip-electrode array that connects to amicro-stimulation current generating device, for application of themicrocurrent stimulation therapy. In some embodiments, the apparatusincludes a headset device for mounting to the patient's head; and one ormore electrode strips such as a one-use disposable chip-electrode arrayhaving a unique serial number or crypto code and other functionalitythat is used by the system to look up and deliver customized therapy toa particular patient having their own particular symptoms and medicalhistory, which deliver the stimulation to the patient's skin.

In some embodiments, the present invention provides a method forapplying bio-electric microcurrent stimulation therapy to the human bodyof a particular patient, via a disposable chip-electrode array stripssuch as a one-use disposable chip-electrode array having a unique serialnumber or crypto code that connects to a micro-stimulation currentgenerating headset, for application of the microcurrent stimulationtherapy. This method includes mounting the headset to the patient'shead; applying one or more electrode strips to the patient's skin;connecting the one or more electrode strips to the headset;communicating the unique serial number or crypto code to a computerserver; using the unique serial number or crypto code in the computerserver to look up and return a customized therapy regimen specificationto the headset for the a particular patient having their own particularsymptoms and medical history; and using the customized therapy regimenspecification, deliver the microcurrent stimulation to the patient'sskin.

In some embodiments, the present invention provides a non-transitorycomputer-readable medium having instructions stored thereon for causinga suitably programmed information processor to execute a method forapplying bio-electric microcurrent stimulation therapy to the human bodyof a particular patient, via a disposable chip-electrode array stripssuch as a one-use disposable chip-electrode array having a unique serialnumber or crypto code that connects to a micro-stimulation currentgenerating headset, for application of the microcurrent stimulationtherapy. This method includes mounting the headset to the patient'shead; applying one or more electrode strips to the patient's skin;connecting the one or more electrode strips to the headset. Theinstructions cause the suitably programmed information processor toexecute a method that includes: communicating the unique serial numberor crypto code to a computer server; using the unique serial number orcrypto code in the computer server to look up and return a customizedtherapy regimen specification to the headset for the a particularpatient having their own particular symptoms and medical history; andusing the customized therapy regimen specification, deliver themicrocurrent stimulation to the patient's skin.

In some embodiments, the present invention provides a system forapplying bio-electric microcurrent stimulation therapy to a patient, thesystem including a head-mounted device configured to be mounted to thepatient's head; a chip-electrode-array circuit operatively coupled tothe head-mounted device, wherein the chip-electrode-array circuitincludes at least one integrated-circuit chip and at least oneelectrode-array strip configured to deliver the bio-electricmicrocurrent stimulation therapy to the patient, wherein thechip-electrode-array circuit includes a unique identification number;and a computer server operatively coupled to the chip-electrode-arraycircuit, wherein the chip-electrode-array circuit is configured tocommunicate with the computer server in order to have the computerserver look up and receiver parameters based at least in part on theunique identification number and communicated the looked-up parametersto the chip-electrode-array circuit for the bio-electric microcurrentstimulation therapy.

In some embodiments of the system, the parameters are further based onparticular symptoms and medical history associated with the patient. Insome embodiments, the unique identification number is a serial numberstored in the at least one integrated-circuit chip and communicated fromthe at least one integrated-circuit chip to the computer server. In someembodiments, the unique identification number is a serial number printedon the at least one electrode-array strip and read by a camera to obtainimage data that is communicated to the computer server. In someembodiments, the chip-electrode-array circuit is a one-use disposablechip-electrode-array circuit. In some embodiments, the uniqueidentification number includes public-key encryption information that isused by the computer server to encrypt data sent to thechip-electrode-array circuit. In some embodiments, the computer serverincludes a medical-results-and-indication database, wherein results ofthe bio-electric microcurrent stimulation therapy are transmitted to themedical-results-and-indication database to be analyzed in order toimprove future therapy sessions.

In some embodiments of the system, the chip-electrode-array circuitincludes a microprocessor integrated with the chip-electrode-arraycircuit. In some embodiments, the system further includes a localmicroprocessor system operatively coupled to the chip-electrode-arraycircuit. In some embodiments, the system further includes a localmicroprocessor system operatively coupled to the chip-electrode-arraycircuit, wherein the local microprocessor system includes a firstportion located on the head-mounted device and a second portion locatedremotely from the head-mounted device.

In some embodiments, the present invention provides a method forapplying bio-electric microcurrent stimulation therapy to a patient viaa chip-electrode-array circuit that includes at least oneintegrated-circuit chip, at least one electrode-array strip, and aunique identification number, the method including providing ahead-mounted device; connecting the at least one electrode-array stripto the head-mounted device; mounting the head-mounted device to thepatient's head such that the head-mounted device applies the at leastone electrode-array strip to the patient's skin; transmittinginformation from the chip-electrode-array circuit to a computer server,wherein the transmitted information includes the unique identificationnumber; receiving into the chip-electrode-array circuit, from thecomputer server, parameters for the bio-electric microcurrentstimulation therapy, wherein the received parameters are based at leastin part on the unique identification number; and delivering, via the atleast one electrode-array strip, the bio-electric microcurrentstimulation therapy to the patient based on the received parameters.

In some embodiments of the method, the received parameters are furtherbased on particular symptoms and medical history associated with thepatient. In some embodiments, the unique identification number is aserial number stored in the at least one integrated-circuit chip, andwherein the transmitting of the information includes communicating theserial number from the at least one integrated-circuit chip to thecomputer server. In some embodiments, the unique identification numberis a serial number printed on the at least one electrode-array strip,and wherein the transmitting of the information includes reading, usinga camera, the printed serial number to obtain image data andcommunicating the obtained image data to the computer server. In someembodiments, the chip-electrode-array circuit is a one-use disposablechip-electrode-array circuit. In some embodiments, the uniqueidentification number includes public-key encryption information, themethod further comprising encrypting data sent to thechip-electrode-array circuit from the computer server using thepublic-key encryption information.

In some embodiments, the method further includes transmitting results ofthe bio-electric microcurrent stimulation therapy to a database locatedon the computer server; and analyzing the results in order to improvefuture therapy sessions. In some embodiments, the method furtherincludes integrating a microprocessor with the chip-electrode-arraycircuit. In some embodiments, the method further includes providing alocal microprocessor system; and coupling the local microprocessorsystem to the chip-electrode-array circuit. In some embodiments, themethod further includes providing a local microprocessor system, whereinthe local microprocessor system includes a first portion and a secondportion; and coupling the first portion of the local microprocessorsystem to the head-mounted device, wherein the second portion of thelocal microprocessor system is located remotely from the head-mounteddevice.

In some embodiments, the present invention provides a non-transitorycomputer-readable medium having instructions stored thereon for causinga suitably programmed information processor to execute a method forapplying bio-electric microcurrent stimulation therapy to a patient viaa chip-electrode-array circuit that includes at least oneintegrated-circuit chip, at least one electrode-array strip, and aunique identification number, wherein the chip-electrode-array circuitis coupled to a head-mounted device, the method including transmittinginformation from the chip-electrode-array circuit to a computer server,wherein the transmitted information includes the unique identificationnumber; receiving into the chip-electrode-array circuit, from thecomputer server, parameters for the bio-electric microcurrentstimulation therapy, wherein the received parameters are based at leastin part on the unique identification number; and delivering, via the atleast one electrode-array strip, the bio-electric microcurrentstimulation therapy to the patient based on the received parameters.

In some embodiments, the non-transitory computer-readable medium furtherincludes instructions such that the received parameters are furtherbased on particular symptoms and medical history associated with thepatient. In some embodiments, the non-transitory computer-readablemedium further includes instructions such that the unique identificationnumber is a serial number stored in the at least one integrated-circuitchip, and wherein the transmitting of the information includescommunicating the serial number from the at least one integrated-circuitchip to the computer server. In some embodiments, the non-transitorycomputer-readable medium further includes instructions such that theunique identification number is a serial number printed on the at leastone electrode-array strip, and wherein the transmitting of theinformation includes reading, using a camera, the printed serial numberto obtain image data and communicating the obtained image data to thecomputer server. In some embodiments, the non-transitorycomputer-readable medium further includes instructions such that theunique identification number includes public-key encryption information,the non-transitory computer-readable medium further includinginstructions such that the method further includes encrypting data sentto the chip-electrode-array circuit from the computer server using thepublic-key encryption information.

In some embodiments, the non-transitory computer-readable medium furtherincludes instructions such that the method further includes transmittingresults of the bio-electric microcurrent stimulation therapy to adatabase located on the computer server; and analyzing the results inorder to improve future therapy sessions.

In some embodiments, the present invention provides an apparatus forapplying bio-electric microcurrent stimulation therapy to a patient, theapparatus including a head-mounted device configured to mount to a headof the patient; a plurality of electrodes coupled to the head-mounteddevice such that the plurality of electrodes contact the patient at aplurality of contact points when the head-mounted device is worn by thepatient, wherein the plurality of electrodes is configured to deliverthe bio-electric microcurrent stimulation therapy to the patient via theplurality of contact points; a controller operatively coupled to theplurality of electrodes and configured to control electrical currentthat passes through the plurality of electrodes during delivery of thebio-electric microcurrent stimulation therapy; and a pressure deviceconfigured to control a contact pressure of the plurality of electrodesat the plurality of contact points.

In some embodiments, the apparatus further includes at least a firstground electrode coupled to the head-mounted device and configured to beplaced at a ground location on the patient. In some embodiments, thehead-mounted device includes a display configured to present informationrelated to the bio-electric microcurrent stimulation therapy. In someembodiments, the head-mounted device includes a plurality oflight-emitting-diodes (LEDs) configured to provide light signals thatprovide information related to the bio-electric microcurrent stimulationtherapy. In some embodiments, the head-mounted device includes at leasta first haptic vibration device configured to provide vibration thatprovides information related to the bio-electric microcurrentstimulation therapy. In some embodiments, the plurality of electrodes ispart of at least a first disposable chip-electrode-array circuit. Insome embodiments, the plurality of electrodes is part of at least afirst disposable chip-electrode-array circuit on a flexible substrate,wherein the flexible substrate further includes an adhesive layer andelectrically conductive gel. In some embodiments, the controller isbuilt into the head-mounted device. In some embodiments, the controlleris located separately from the head-mounted device and is wirelesslycoupled to the head-mounted device.

In some embodiments of the apparatus, the plurality of electrodes ispart of at least a first disposable chip-electrode-array circuit thatincludes a unique serial number (USN) that identifies the at least firstdisposable chip-electrode-array circuit and allows encryptedcommunications between the controller and a remote server that containsmedical and therapy information associated with the patient. In someembodiments, the apparatus further includes sensors operatively coupledto the controller and configured to provide feedback related to thebio-electric microcurrent stimulation therapy.

In some embodiments of the apparatus, the pressure device includes alens cover coupled to the head-mounted device and configured to contactthe plurality of electrodes to apply pressure between the plurality ofelectrodes and the plurality of contact points. In some embodiments, thepressure device includes a lens cover coupled to the head-mounted deviceand configured to contact the plurality of electrodes to apply pressurebetween the plurality of electrodes and the plurality of contact points,wherein the lens cover is spring-mounted such that the lens cover isconfigured to flip between a first position that contacts the pluralityof electrodes and a second position that is not in contact with theplurality of electrodes. In some embodiments, the pressure deviceincludes a lens cover coupled to the head-mounted device and configuredto contact the plurality of electrodes to apply pressure between theplurality of electrodes and the plurality of contact points, theapparatus further including sensors operatively coupled to thecontroller and configured to provide feedback related to thebio-electric microcurrent stimulation therapy.

In some embodiments, the present invention provides a method forapplying bio-electric microcurrent stimulation therapy to a patient viaa disposable chip-electrode-array circuit that connects to amicro-stimulation current generating head-mounted device, the methodincluding mounting the head-mounted device to the patient's head;applying one or more electrode strips of the disposablechip-electrode-array circuit to a plurality of contact points on thepatient's skin; connecting the one or more electrode strips to thehead-mounted device; controlling electrical current that passes throughthe one or more electrode strips during delivery of the bio-electricmicrocurrent stimulation therapy; and controlling a contact pressure ofthe one or more electrode strips at the plurality of contact points.

In some embodiments, the method further includes providing a firstground electrode; coupling the first ground electrode to thehead-mounted device; and placing the first ground electrode at a groundlocation on the patient. In some embodiments, the method furtherincludes displaying information related to the bio-electric microcurrentstimulation therapy. In some embodiments, the head-mounted deviceincludes a plurality of light-emitting-diodes (LEDs), the method furtherincluding generating light signals using the plurality of LEDs in orderto provide information related to the bio-electric microcurrentstimulation therapy. In some embodiments, the head-mounted deviceincludes at least a first haptic vibration device, the method furtherincluding generating vibration signals using the at least first hapticvibration device in order to provide information related to thebio-electric microcurrent stimulation therapy.

In some embodiments, the method further includes providing a flexiblesubstrate that includes an adhesive layer and electrically conductivegel; and mounting the at least a first disposable chip-electrode-arraycircuit on the flexible substrate. In some embodiments, the controllingof the electrical current occurs within the head-mounted device. In someembodiments, the controlling of the electrical current occurs remotefrom the head-mounted device. In some embodiments, the disposablechip-electrode-array circuit includes a unique serial number (USN) thatidentifies the disposable chip-electrode-array circuit for a remoteserver that contains medical and therapy information associated with thepatient, wherein the controlling of the electrical current includestransmitting and receiving encrypted communications between thehead-mounted device and the remote server.

In some embodiments, the method further includes providing one or moresensors operatively coupled to the head-mounted device, wherein thecontrolling of the electrical current includes receiving feedback fromthe one or more sensors during the applying of the bio-electricmicrocurrent stimulation therapy. In some embodiments, the methodfurther includes providing a lens cover coupled to the head-mounteddevice, wherein the controlling of the contact pressure of the one ormore electrode strips includes pushing the lens cover into the one ormore electrode strips to apply pressure between the plurality ofelectrodes and the plurality of contact points. In some embodiments, themethod further includes providing a lens cover coupled to thehead-mounted device, wherein the controlling of the contact pressure ofthe one or more electrode strips includes flipping the lens coverbetween a first position that contacts the one or more electrode stripsand a second position that is not in contact with the one or moreelectrode strips. In some embodiments, the method further includesproviding a lens cover coupled to the head-mounted device, wherein thecontrolling of the contact pressure of the one or more electrode stripsincludes flipping the lens cover between a first position that contactsthe one or more electrode strips and a second position that is not incontact with the one or more electrode strips; and providing one or moresensors operatively coupled to the head-mounted device, wherein thecontrolling of the electrical current includes receiving feedback fromthe one or more sensors during the applying of the bio-electricmicrocurrent stimulation therapy.

In some embodiments, the present invention provides a system forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the system including afirst stimulation strip that includes a first elongated portionconfigured to be placed on the upper eyelid of the first eye of thepatient and a second elongated portion configured to be placed on thelower eyelid of the first eye of the patient, wherein the firststimulation strip includes: a first plurality of individually controlledelectrodes, wherein the first plurality of individually controlledelectrodes is configured to deliver therapy that includes a sequence orseries of spatially and temporally separated microcurrent stimulation ofvaried pulsed intensity (e.g., wherein “intensity” means pulses of agiven current level) to the patient's first eye, and a first pluralityof light emitters, wherein the first plurality of light emitters isconfigured to deliver a sequence or series of spatially and temporallyseparated light-stimulation therapy of varied intensity (e.g., pulses)to the patient; and a controller operatively coupled to the firstbifurcated stimulation strip and configured to control delivery of themicrocurrent stimulation therapy and the light stimulation therapy.

In some embodiments, the “pulsed” electrical stimulation from a firstelectrode to a second electrode includes both positive-voltage pulsesalternated with negative-voltage pulses in order to avoid charge buildupin the tissue. For example, in some embodiments, a single pulse in apositive-voltage direction is followed by a single pulse in anegative-voltage direction, wherein the amplitude and duration of thepositive-voltage direction pulse and the amplitude and duration of thenegative-voltage direction pulse are each selected so that one offsetsthe other to avoid charge buildup in the cells in the electrical pathbetween the first electrode and the second electrode. In otherembodiments, one or more pulses in the positive-voltage direction arefollowed by one or more pulses in a negative-voltage direction. In yetother embodiments, the stimulation includes an alternating current (AC)waveform that is amplitude modulated by gating pulses such that aplurality of the AC cycles are passed by the amplitude modulated gatingpulses.

In some embodiments of the system, each respective electrode of thefirst plurality of electrodes contacts the patient at a respectivecontact pressure, the system further including a pressure-control devicecoupled to the first bifurcated strip and configured to selectivelymaintain the respective contact pressure of each respective electrode ina range of two (2) ounces per square inch (about 0.862 kilopascals) tofifteen (15) pounds per square inch (about 103.4 kilopascals). In someembodiments, each respective electrode of the first plurality ofelectrodes contacts the patient at a respective contact point and at arespective contact pressure, the system further including apressure-control device coupled to the first bifurcated strip andconfigured to selectively maintain the respective contact pressure ofeach respective electrode in a range of two (2) ounces per square inch(0.862 kilopascals) to fifteen (15) pounds per square inch (103.4kilopascals), wherein the pressure-control device is configured toprovide a negative pressure such that skin of the respective contactpoint is pulled toward the respective electrode.

In some embodiments of the system, the controller is configured tocontrol the first plurality of electrodes and the first plurality oflight emitters such that the microcurrent stimulation therapy isdelivered simultaneously with the delivery of the light stimulationtherapy. In some embodiments, the controller is configured to controlthe first plurality of electrodes and the first plurality of lightemitters such that the microcurrent stimulation therapy is deliveredduring a first time period and the light stimulation therapy isdelivered during a second time period that follows the first timeperiod.

In some embodiments, the present invention provides a system forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the system including afirst bifurcated stimulation strip that includes a first elongatedportion configured to be placed on the upper eyelid of the first eye ofthe patient and a second elongated portion configured to be placed onthe lower eyelid of the first eye of the patient, wherein the firstbifurcated stimulation strip includes: a first plurality of electrodes,wherein a first sub-plurality of the first plurality of electrodes isconfigured to deliver a microcurrent stimulation therapy to the patient,and wherein a second sub-plurality of the first plurality of electrodesis configured to deliver a heat therapy to the patient; and a controlleroperatively coupled to the first bifurcated stimulation strip andconfigured to control delivery of the microcurrent stimulation therapyand the heat therapy.

In some embodiments of the system, the controller is configured tocontrol the first plurality of electrodes such that the microcurrentstimulation therapy is delivered simultaneously with the delivery of theheat therapy. In some embodiments, the controller is configured tocontrol the first plurality of electrodes such that the heat therapy isdelivered during a first time period and the microcurrent stimulationtherapy is delivered during a second timer period that follows the firsttime period. In some embodiments, the controller is configured tocontrol the first sub-plurality of the first plurality of electrodessuch that the microcurrent stimulation therapy is delivered via acontinuous microcurrent. In some embodiments, the controller isconfigured to control the first sub-plurality of the first plurality ofelectrodes such that the microcurrent stimulation therapy is deliveredvia a pulsed microcurrent.

In some embodiments, the present invention provides a system forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the system including afirst bifurcated stimulation strip that includes a first elongatedportion configured to be placed on the upper eyelid of the first eye ofthe patient and a second elongated portion configured to be placed onthe lower eyelid of the first eye of the patient, wherein the firstbifurcated stimulation strip includes: a plurality of electrodes,wherein the plurality of electrodes is configured to deliver amicrocurrent stimulation therapy to the patient, and a plurality oflight emitters, wherein the plurality of light emitters is configured todeliver light stimulation therapy to the patient, and wherein the firstbifurcated stimulation strip is further configured to deliver a heattherapy to the patient; and a controller operatively coupled to thefirst bifurcated stimulation strip and configured to control delivery ofthe microcurrent stimulation therapy, the heat therapy, and the lightstimulation therapy.

In some embodiments, the present invention provides a system forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the system including: afirst stimulation strip that includes a first elongated portionconfigured to be placed on the upper eyelid of the first eye of thepatient and a second elongated portion configured to be placed on thelower eyelid of the first eye of the patient, wherein the firststimulation strip includes: a first plurality of individually controlledelectrodes, wherein the first plurality of individually controlledelectrodes is configured to deliver microcurrent stimulation therapy tothe patient's first eye, and a first plurality of individuallycontrolled light emitters, wherein the first plurality of individuallycontrolled light emitters is configured to deliver light-stimulationtherapy to the patient's first eye; and a controller operatively coupledto the first stimulation strip and configured to control delivery of themicrocurrent stimulation therapy and the light stimulation therapy tothe patient's first eye.

In some embodiments of the system, each respective electrode of thefirst plurality of electrodes contacts the patient at a respectivecontact pressure, the system further including: a pressure-controldevice coupled to the first strip and configured to selectively maintainthe respective contact pressure of each respective electrode at a valuein a range of two (2) ounces per square inch (0.862 kilopascals) tofifteen (15) pounds per square inch (103.4 kilopascals), inclusive,which, in some embodiments, is delivered to a “pinpointed” area for eachelectrode of, for example, 2 to 225 square millimeters (1.4 mm*1.4 mm=2mm² to 15 mm*15 mm=225 mm²). In some embodiments, the respectiveincremental contact pressure (in addition to normal atmospheric pressureof air on the skin) of each respective electrode is selectivelymaintained at a value of three (3) ounces per square inch (1.29kilopascals), four (4) ounces per square inch (1.72 kilopascals), five(5) ounces per square inch (2.15 kilopascals), ten (10) ounces persquare inch (4.31 kilopascals), fifteen (15) ounces per square inch(6.46 kilopascals), one pound per square inch (6.89 kilopascals), twopounds per square inch (13.8 kilopascals), or any other suitablepressure value (in some such embodiments, the pressure value is set suchthat an impedance associated with the delivery of the microcurrentstimulation therapy is eliminated or minimized). In some embodiments,the respective contact pressure of each respective electrode ismaintained at a value in a range of two (2) ounces per square inch(0.862 kilopascals) to one pound per square inch (6.89 kilopascals),inclusive; a range of eight (8) ounces per square inch (3.45kilopascals) to one-and-a-half pounds per square inch (10.3kilopascals), inclusive; a range of one (1) pound per square inch (6.89kilopascals) to two pounds per square inch (13.8 kilopascals),inclusive, In some embodiments, the respective contact pressure of eachrespective electrode is individually maintained at a selected pressurevalue (e.g., in some embodiments, the contact pressure of a firstrespective electrode is maintained at a value of three (3) ounces persquare inch (1.29 kilopascals) while the contact pressure of a secondrespective electrode is maintained at a value of four (4) ounces persquare inch (1.72 kilopascals)).

In some embodiments, each respective electrode of the first plurality ofelectrodes contacts the patient at a respective contact point and at arespective contact pressure, the system further including apressure-control device coupled to the first strip and configured toselectively maintain the respective contact pressure of each respectiveelectrode in a range of two (2) ounces per square inch (0.862kilopascals) to fifteen (15) pounds per square inch (103.4 kilopascals),wherein the pressure-control device generates the respective contactpressure by creating a vacuum such that skin of the respective contactpoint is pulled toward the respective electrode.

In some embodiments of the system, the controller is configured tocontrol the first plurality of electrodes and the first plurality oflight emitters such that the microcurrent stimulation therapy isdelivered simultaneously with the delivery of the light stimulationtherapy (e.g., in a manner such as described in U.S. Pat. No. 8,160,696,which is incorporated by reference above). In some embodiments, thecontroller is configured to control the first plurality of electrodesand the first plurality of light emitters such that the microcurrentstimulation therapy is delivered during a first time period and thelight-stimulation therapy is delivered during a second timer period thatfollows the first time period (e.g., in a manner such as described inU.S. Pat. No. 8,160,696, which is incorporated by reference above).

In some embodiments of the system, the first plurality of electrodesincludes a single-use, disposable electrode-strip housing that containsa respective gelled contact point for each respective one of the firstplurality of electrodes, wherein the electrode-strip housing isconfigured to removably couple to the first plurality of electrodes(e.g., the electrode-strip housing snaps into the first plurality ofelectrodes), and wherein the electrode-strip housing includes a peel-offcover that is removed to expose each respective gelled contact point.

In some embodiments of the system, the first stimulation strip iscoupled to a headset device configured to be placed on a head of thepatient, wherein the first plurality of electrodes is part of adisposable (e.g., single use) housing that includes a respective gelledcontact point for each respective one of the first plurality ofelectrodes, wherein the housing is configured to removably couple to theheadset device, and wherein the housing includes a peel-off cover thatis removed to expose each respective gelled contact point.

In some embodiments, the system further includes a stimulator signalgenerator operatively coupled to the first plurality of individuallycontrolled electrodes and configured to generate the microcurrentstimulation therapy signals delivered by the first plurality ofindividually controlled electrodes. In some such embodiments, thestimulator signal generator is placed on (or near) a temple of thepatient. In some embodiments, the microcurrent stimulation therapyincludes a series of spatially and temporally separated microcurrentpulses. In some embodiments, the light-stimulation therapy includes aseries of spatially and temporally separated light pulses.

In some embodiments, the system further includes an audio-output unitconfigured to provide a sound (beep, chime, ding, or the like) toindicate a characteristic of the microcurrent stimulation therapy(and/or the light-stimulation therapy) (e.g., indicate that themicrocurrent stimulation therapy has started/ended, indicate that themicrocurrent stimulation therapy is malfunctioning, and the like).

In some embodiments, the system further includes: a second stimulationstrip that includes a first elongated portion configured to be placed onthe upper eyelid of the second eye of the patient and a second elongatedportion configured to be placed on the lower eyelid of the second eye ofthe patient, wherein the second stimulation strip includes: a secondplurality of individually controlled electrodes, wherein the secondplurality of individually controlled electrodes is configured to delivermicrocurrent stimulation therapy to the patient's second eye, and asecond plurality of individually controlled light emitters, wherein thesecond plurality of individually controlled light emitters is configuredto deliver light-stimulation therapy to the patient's second eye;wherein the controller is operatively coupled to the second stimulationstrip and the controller is further configured to control delivery ofthe microcurrent stimulation therapy and the light stimulation therapyto the patient's second eye. In some embodiments, at least one selectedfrom the group consisting of microcurrent stimulation therapy andlight-stimulation therapy is delivered to the patient's first eye andthe patient's second eye simultaneously. In some embodiments, at leastone selected from the group consisting of microcurrent stimulationtherapy and light-stimulation therapy is delivered to the patient'sfirst eye during a first time period, wherein at least one selected fromthe group consisting of microcurrent stimulation therapy andlight-stimulation therapy is delivered to the patient's second eyeduring a second time period, and wherein the second time period occursafter the first time period.

In some embodiments of the system, the light-stimulation therapy isdelivered as a continuous wave of light energy. In some embodiments, thelight-stimulation therapy is delivered as a plurality of light pulses.In some embodiments, at least one selected from the group consisting ofthe microcurrent therapy and the light-stimulation therapy is deliveredin a plurality of cycles, wherein each pair of sequential cycles withinthe plurality of cycles is separated by a rest period (e.g., a restperiod in a range of 60 seconds to ten (10) minutes). In someembodiments, the first stimulation strip further includes a groundelectrode operatively coupled to the first plurality of electrodes andconfigured to be placed on the patient (e.g., on or near the eyelids orother location on the head, neck, shoulder, chest, or any other suitablepart of the patient). In some embodiments, the first stimulation stripis coupled to a headset device configured to be placed on a head of thepatient. In some embodiments, the first stimulation strip is coupled toa headset device configured to be placed on a head of the patient, andwherein the headset device includes the controller. In some embodiments,the first stimulation strip includes a microchip, and wherein thecontroller communicates wirelessly with the microchip. In someembodiments, the first plurality of electrodes is coupled to thecontroller via a three-layer wiring, and wherein the three-layer wiringincludes an interference-blocking layer.

In some embodiments, the present invention provides a system forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the system including: afirst stimulation strip that includes a first elongated portionconfigured to be placed on the upper eyelid of the first eye of thepatient and a second elongated portion configured to be placed on thelower eyelid of the first eye of the patient, wherein the firststimulation strip includes: a first plurality of individually controlledelectrodes configured to deliver microcurrent stimulation therapy to thepatient's first eye, a first plurality of individually controlled heatsources configured to deliver heat therapy to the patient's first eye;and a controller operatively coupled to the first stimulation strip andconfigured to control delivery of the microcurrent stimulation therapyand the heat therapy to the patient's first eye. In some embodiments,the controller is configured to control the first plurality ofelectrodes such that the microcurrent stimulation therapy is deliveredsimultaneously with the delivery of the heat therapy. In someembodiments, the heat therapy is delivered during a first time periodand the microcurrent stimulation therapy is delivered during a secondtimer period that follows the first time period. In some embodiments,the controller is configured to control the first plurality ofelectrodes such that the microcurrent stimulation therapy is deliveredvia a continuous microcurrent. In some embodiments, the controller isconfigured to control the first plurality of electrodes such that themicrocurrent stimulation therapy is delivered via a pulsed microcurrent.In some embodiments, the system further includes a trans-cranialmagnetic pulse generator operatively coupled to the controller andconfigured to provide pulsed electromagnetic field (PEMF) therapy to thepatient (e.g., eyelids or other areas near the first and/or second eyeof the patient). In some embodiments, the first plurality ofindividually controlled electrodes is further configured to provide highvoltage pulsed current (HVPC) therapy to the patient (e.g., the firstand/or second eye of the patient). In some embodiments, the firstplurality of individually controlled electrodes is further configured toprovide low voltage pulsed current (LVPC) therapy to the patient (e.g.,the first and/or second eye of the patient).

In some embodiments of the system, the first plurality of heat sourcesincludes a plurality of electrically-driven heat elements. In someembodiments of the system, the first plurality of heat sources includesa dual heat sourced electrode that can individually activate heat ateither one or more of the upper-eyelid electrode(s) or one or more ofthe bottom eyelid electrode(s), or activate both upper and lowersimultaneously. In some embodiments, the microcurrent stimulationtherapy is delivered simultaneously with the delivery of the heattherapy. In some embodiments, the heat therapy is delivered during afirst time period, wherein the microcurrent stimulation therapy isdelivered during a second time period, and wherein the second timeperiod occurs after the first time period.

In some embodiments, the system further includes a second stimulationstrip that includes a first elongated portion configured to be placed onthe upper eyelid of the second eye of the patient and a second elongatedportion configured to be placed on the lower eyelid of the second eye ofthe patient, wherein the second stimulation strip includes: a secondplurality of individually controlled electrodes, wherein the secondplurality of individually controlled electrodes is configured to delivermicrocurrent stimulation therapy to the patient's second eye, and asecond plurality of individually controlled heat sources configured todeliver a heat therapy to the patient's second eye; wherein thecontroller is operatively coupled to the second stimulation strip andthe controller is further configured to control delivery of themicrocurrent stimulation therapy and the heat therapy to the patient'ssecond eye.

In some embodiments of the system, at least one selected from the groupconsisting of microcurrent stimulation therapy and heat therapy isdelivered to the patient's first eye and the patient's second eyesimultaneously. In some embodiments, at least one selected from thegroup consisting of microcurrent stimulation therapy and heat therapy isdelivered to the patient's first eye during a first time period, whereinat least one selected from the group consisting of microcurrentstimulation therapy and heat therapy is delivered to the patient'ssecond eye during a second time period, and wherein the second timeperiod occurs after the first time period.

In some embodiments, the heat therapy is configured to increase bloodflow to the back of the patient's first eye (and blood temperature tothe eye region), and in some embodiments, the heat therapy is deliveredto change the temperature of the tissue of the patient to achieve atissue temperature value in a range of approximately 36.6 degreesCelsius (98 degrees Fahrenheit) to approximately 43 degrees Celsius(approximately 109.4 degrees Fahrenheit), inclusive, and for a therapytime period in a range from one (1) second to thirty (30) minutes,inclusive. For example, in some embodiments, a therapy time period of 30seconds, 60 seconds, two minutes, five minutes, 10 minutes, 20 minutes,30 minutes, or any other suitable time period). In some embodiments, theheat therapy is delivered at a temperature value in a range ofapproximately 36.6 degrees Celsius (98 degrees Fahrenheit) toapproximately 48.9 degrees Celsius (approximately 120 degreesFahrenheit), inclusive. In some embodiments, the heat therapy is appliedin a controlled temperature-change-per-unit-time manner to preventthermal shock that might damage tissue or cause discomfort to thepatient. In some embodiments, the rate of temperature rise (or fall) ismaintained at a rate of no more than one degree Celsius per 10 seconds,a rate of no more than one degree Celsius per 20 seconds, a rate of nomore than one degree Celsius per 30 seconds, a rate of no more than onedegree Celsius per 40 seconds, a rate of no more than one degree Celsiusper 50 seconds, or a rate of no more than one degree Celsius per 60seconds. In some such embodiments, the rate of change of temperature isvaried as the temperature is raised or lowered. In some suchembodiments, a temperature sensor is used to obtain temperatureparameters at the stimulation strip, and the controller adjusts thecurrent supplied to the resistive heaters on the stimulation strip tocontrol the rate of temperature change, in a manner modified fromwhole-body hyperthermia methods such as described in U.S. Pat. No.5,730,720 to Sites et al., but rather than perfusing blood or otherfluid into the patient as described by Sites et al., the presentinvention applies heat at a controlled rate to the outer skin of thepatient via resistive or other heat-generation devices on thestimulation strip or on the goggle-like devices that press thestimulation strip against the skin of the patient. In other embodiments,a thermo-electric cooler (such as a Peltier device) is used to cool theskin at the electrode locations, and in some such embodiments, thepresent invention applies cooling at a controlled rate, and then at theend of the therapy session, raises the temperature at a controlled rate.

In some embodiments, the first stimulation strip includes one or moretemperature sensors configured to sense a temperature of the patient'stissue at the contact point of the heat (or cooling) source such thatthe heat therapy is delivered based on the sensed temperature of thepatient's tissue at the contact point. In some embodiments, the heattherapy is delivered such that the sensed temperature of the patient'stissue at the contact point is approximately 37 degrees Celsius,approximately 37.5 degrees Celsius, approximately 38 degrees Celsius,approximately 38.5 degrees Celsius, approximately 39 degrees Celsius,approximately 39.5 degrees Celsius, approximately 40 degrees Celsius,approximately 41 degrees Celsius, approximately 42 degrees Celsius,approximately 42.5 degrees Celsius, or any other suitable temperature.In some embodiments, the temperature is kept at or below 43 degreesCelsius to avoid thermal damage to the tissue. In some embodiments, thetemperature rate of change is kept at or below one degree Celsius per 20seconds to avoid thermal-shock damage to the tissue or discomfort to thepatient. In some embodiments, each respective electrode of the firstplurality of electrodes contacts the patient at a respective contactpoint, wherein the first plurality of heat sources includes a first heatsource located at a first respective contact point and a second heatsource located at a second respective contact point, wherein the heattherapy includes delivery of heat for a first time period via the firstheat source, and delivery of heat for a second time period via thesecond heat source. In some embodiments, each of the first plurality ofheat sources is configured to deliver the heat therapy simultaneouslysuch that a majority portion of the first stimulation strip is heatedduring delivery of the heat therapy.

In some embodiments of the system, at least one selected from the groupconsisting of the microcurrent therapy and the heat therapy is deliveredin a plurality of cycles, wherein each pair of sequential cycles withinthe plurality of cycles is separated by a rest period (e.g., a restperiod in a range of 60 seconds to ten (10) minutes, inclusive; in someembodiments, a rest period of 90 seconds, a rest period of 120 seconds,a rest period of 180 seconds, a rest period of 240 seconds, a restperiod of five minutes, a rest period of six minutes, a rest period ofseven minutes, a rest period of eight minutes, a rest period of nineminutes, a rest period of ten minutes, or any other suitable rest periodbetween each therapy time period). In some embodiments, the firststimulation strip further includes a ground electrode operativelycoupled to the first plurality of electrodes and configured to be placedon a head of the patient. In some embodiments, the first stimulationstrip is coupled to a headset device configured to be placed on a headof the patient. In some embodiments, the first stimulation strip iscoupled to a headset device configured to be placed on a head of thepatient, and wherein the headset device includes the controller. In someembodiments, the first stimulation strip includes a microchip, whereinthe controller communicates wirelessly with the microchip.

In some embodiments, the present invention provides a system forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the system including afirst stimulation strip that includes a first elongated portionconfigured to be placed on the upper eyelid of the first eye of thepatient and a second elongated portion configured to be placed on thelower eyelid of the first eye of the patient, wherein the firststimulation strip includes: a first plurality of individually controlledelectrodes, wherein the first plurality of electrodes is configured todeliver a microcurrent stimulation therapy to the patient's first eye,and a first plurality of individually controlled light emitters, whereinthe first plurality of light emitters is configured to deliverlight-stimulation therapy to the patient's first eye, a first pluralityof individually controlled heat sources configured to deliver heattherapy to the patient's first eye; and a controller operatively coupledto the first stimulation strip and configured to control delivery of themicrocurrent stimulation therapy, the light-stimulation therapy, and theheat therapy to the patient's first eye.

In some embodiments of the system, the microcurrent stimulation therapy,the light-stimulation therapy, and the heat therapy are deliveredsimultaneously. In some embodiments, the microcurrent stimulationtherapy is delivered during a first time period, wherein thelight-stimulation therapy is delivered during a second time period, andwherein the heat therapy is delivered during a third time period.

In some embodiments, the system further includes: a second stimulationstrip that includes a first elongated portion configured to be placed onthe upper eyelid of the second eye of the patient and a second elongatedportion configured to be placed on the lower eyelid of the second eye ofthe patient, wherein the second stimulation strip includes: a secondplurality of individually controlled electrodes, wherein the secondplurality of individually controlled electrodes is configured to delivermicrocurrent stimulation therapy to the patient's second eye, and asecond plurality of individually controlled light emitters, wherein thesecond plurality of individually controlled light emitters is configuredto deliver light-stimulation therapy to the patient's second eye, asecond plurality of individually controlled heat sources configured todeliver heat therapy to the patient's second eye; wherein the controlleris operatively coupled to the second stimulation strip and thecontroller is further configured to control delivery of the microcurrentstimulation therapy, the light-stimulation therapy, and the heat therapyto the patient's second eye. In some embodiments, at least one selectedfrom the group consisting of microcurrent stimulation therapy,light-stimulation therapy, and heat therapy is delivered to thepatient's first eye and the patient's second eye simultaneously. In someembodiments, at least one selected from the group consisting ofmicrocurrent stimulation therapy, light-stimulation therapy, and heattherapy is delivered to the patient's first eye during a first timeperiod, wherein at least one selected from the group consisting ofmicrocurrent stimulation therapy, light-stimulation therapy, and heattherapy is delivered to the patient's second eye during a second timeperiod, and wherein the second time period occurs after the first timeperiod.

In some embodiments of the system, the heat therapy is configured toincrease blood flow to the back of the patient's first eye, and whereinthe heat therapy is delivered at a temperature in a range ofapproximately 36.6 degrees Celsius (98 degrees Fahrenheit) toapproximately 43 degrees Celsius (approximately 109.4 degreesFahrenheit) and for a time period in a range from one (1) second tothirty (30) minutes (e.g., in some embodiments, 30 seconds). In someembodiments, each respective electrode of the first plurality ofelectrodes contacts the patient at a respective contact point, whereinthe first plurality of heat sources includes a first heat source locatedat a first respective contact point and a second heat source located ata second respective contact point, wherein the heat therapy includesdelivery of heat for a first time period via the first heat source, anddelivery of heat for a second time period via the second heat source. Insome embodiments, each of the first plurality of heat sources isconfigured to deliver the heat therapy simultaneously such that amajority portion of the first stimulation strip is heated duringdelivery of the heat therapy.

In some embodiments, at least one selected from the group consisting ofthe microcurrent therapy, the light-stimulation therapy, and the heattherapy is delivered in a plurality of cycles, wherein each pair ofsequential cycles within the plurality of cycles is separated by a restperiod (e.g., a rest period in a range of 60 seconds to ten (10)minutes). In some embodiments, the light-stimulation therapy isdelivered as a continuous wave of light energy. In some embodiments, thelight-stimulation therapy is delivered as a plurality of light pulses.In some embodiments, the first stimulation strip further includes aground electrode operatively coupled to the first plurality ofelectrodes and configured to be placed on a head of the patient. In someembodiments, the first stimulation strip is coupled to a headset deviceconfigured to be placed on a head of the patient. In some embodiments,the first stimulation strip is coupled to a headset device configured tobe placed on a head of the patient, and wherein the headset deviceincludes the controller. In some embodiments, the first stimulationstrip includes a microchip, and wherein the controller communicateswirelessly with the microchip.

In some embodiments, the present invention provides a method forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the method including:providing a first stimulation strip that includes a first elongatedportion and a second elongated portion, and wherein the firststimulation strip includes a first plurality of individually controlledelectrodes and a first plurality of individually controlled lightemitters; placing the first elongated portion of the first stimulationstrip on the upper eyelid of the first eye of the patient; placing thesecond elongated portion of the first stimulation strip on the lowereyelid of the first eye of the patient; delivering a microcurrentstimulation therapy to the patient's first eye via the first pluralityof individually controlled electrodes; and delivering alight-stimulation therapy to the patient's first eye via the firstplurality of individually controlled light emitters.

In some embodiments of the method, the delivering of the microcurrentstimulation therapy includes ramping up the microcurrent stimulationtherapy from a first microcurrent level during a first time period to asecond microcurrent level during a second time period that follows thefirst time period. In some embodiments, the delivering of themicrocurrent stimulation therapy includes setting a level of themicrocurrent stimulation therapy based on a tolerance of the patient,wherein the tolerance is determined (e.g., at the beginning of atreatment session) by gradually increasing an intensity of themicrocurrent stimulation therapy (e.g., increasing the amplitude ofcurrent in each successive pulse or series of pulses at a rate that isgradual enough to allow the patient to respond to discomfort andindicate to stop the increase in intensity) until the patient providesfeedback indicating that the microcurrent stimulation therapy hasreached an discomfort threshold, and then decreasing the intensity ofthe microcurrent stimulation therapy until the patient provides feedbackindicating that the microcurrent stimulation therapy is below thediscomfort threshold, wherein the level of microcurrent stimulationtherapy is set at the intensity that brings the patient below thediscomfort threshold (in some embodiments, for example, the tolerancemay vary from patient to patient, and the tolerance may vary from day today for a given patient). In some embodiments, the delivering of themicrocurrent stimulation therapy includes setting a level of themicrocurrent stimulation therapy based on a tolerance of the patient,wherein the tolerance is determined by gradually increasing an intensityof the microcurrent stimulation therapy at a rate that allows thepatient to respond to discomfort until the patient provides feedbackindicating that the microcurrent stimulation therapy has reached apatient-indicated discomfort threshold, and then decreasing theintensity by a predetermined amount below the discomfort threshold(e.g., to a level of about 60%, 70%, 80%, or 90% of the intensity thatresulted in the patient indicating discomfort), wherein the level ofmicrocurrent stimulation therapy is set at the intensity that brings thepatient below the discomfort threshold.

In some embodiments of the method, each respective electrode of thefirst plurality of electrodes contacts the patient at a respectivecontact pressure, the method further including selectively maintainingthe respective contact pressure of each respective electrode at a valuein a range of two (2) ounces per square inch (0.862 kilopascals) tofifteen (15) pounds per square inch (103.4 kilopascals). In someembodiments, the delivering of the microcurrent stimulation therapy andthe delivering of the light-stimulation therapy occurs simultaneously.In some embodiments, the delivering of the microcurrent stimulationtherapy occurs during a first time period, wherein the delivering of thelight-stimulation therapy occurs during a second timer period thatfollows the first time period. In some embodiments, the delivering ofthe microcurrent stimulation therapy includes generating and deliveringa series of spatially and temporally separated microcurrent pulses tothe patient's first eye.

In some embodiments, the method further includes: providing a secondstimulation strip that includes a first elongated portion and a secondelongated portion, and wherein the second stimulation strip includes asecond plurality of individually controlled electrodes and a secondplurality of individually controlled light emitters; placing the firstelongated portion of the second stimulation strip on the upper eyelid ofthe second eye of the patient; placing the second elongated portion ofthe second stimulation strip on the lower eyelid of the second eye ofthe patient; delivering a microcurrent stimulation therapy to thepatient's second eye via the second plurality of individually controlledelectrodes; and delivering a light-stimulation therapy to the patient'ssecond eye via the second plurality of individually controlled lightemitters. In some embodiments, the delivering of the microcurrentstimulation therapy to the patient's second eye occurs simultaneouslywith the delivering of the microcurrent stimulation therapy to thepatient's first eye. In some embodiments, the delivering of thelight-stimulation therapy includes generating and delivering acontinuous wave of light energy to the patient's first eye. In someembodiments, the delivering of the light-stimulation therapy includesgenerating and delivering a plurality of light pulses to the patient'sfirst eye.

In some embodiments of the method, the delivering of the microcurrentstimulation therapy and the delivering of the light-stimulation therapyincludes delivering a plurality of stimulation cycles, wherein each pairof sequential cycles within the plurality of cycles is separated by arest period (e.g., a rest period in a range of 60 seconds to ten (10)minutes).

In some embodiments, the present invention provides a method forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the method including:providing a first stimulation strip that includes a first elongatedportion and a second elongated portion, and wherein the firststimulation strip includes a first plurality of individually controlledelectrodes and a first plurality of individually controlled heatsources; placing the first elongated portion of the first stimulationstrip on the upper eyelid of the first eye of the patient; placing thesecond elongated portion of the first stimulation strip on the lowereyelid of the first eye of the patient; delivering a microcurrentstimulation therapy to the patient's first eye via the first pluralityof individually controlled electrodes; and delivering a heat therapy tothe patient's first eye via the first plurality of individuallycontrolled light heat sources.

In some embodiments of the method, each respective electrode of thefirst plurality of electrodes contacts the patient at a respectivecontact pressure, the method further including: selectively maintainingthe respective contact pressure of each respective electrode at a valuein a range of two (2) ounces per square inch (0.862 kilopascals) tofifteen (15) pounds per square inch (103.4 kilopascals). In someembodiments, the delivering of the microcurrent stimulation therapy andthe delivering of the heat therapy occurs simultaneously. In someembodiments, the delivering of the microcurrent stimulation therapyoccurs during a first time period, and wherein the delivering of theheat therapy occurs during a second timer period that follows the firsttime period.

In some embodiments, the method further includes: providing a secondstimulation strip that includes a first elongated portion and a secondelongated portion, and wherein the second stimulation strip includes asecond plurality of individually controlled electrodes and a secondplurality of individually controlled heat sources; placing the firstelongated portion of the second stimulation strip on the upper eyelid ofthe second eye of the patient; placing the second elongated portion ofthe second stimulation strip on the lower eyelid of the second eye ofthe patient; delivering a microcurrent stimulation therapy to thepatient's second eye via the second plurality of individually controlledelectrodes; and delivering a heat therapy to the patient's second eyevia the second plurality of individually controlled heat sources. Insome embodiments, the delivering of the microcurrent stimulation therapyto the patient's second eye occurs simultaneously with the delivering ofthe microcurrent stimulation therapy to the patient's first eye. In someembodiments, the heat therapy is configured to increase blood flow tothe back of the patient's first eye, wherein the delivering of the heattherapy includes setting a temperature of the heat therapy at atemperature value in a range of approximately 36.6 degrees Celsius (98degrees Fahrenheit) to approximately 43 degrees Celsius (approximately109.4 degrees Fahrenheit) and for a time period in a range from one (1)second to thirty (30) minutes (e.g., in some embodiments, 30 seconds).In some embodiments, each respective electrode of the first plurality ofelectrodes contacts the patient at a respective contact point, whereinthe first plurality of heat sources includes a first heat source locatedat a first respective contact point and a second heat source located ata second respective contact point, wherein the delivering of the heattherapy includes delivering heat for a first time period via the firstheat source, and delivering heat for a second time period via the secondheat source. In some embodiments, the delivering of the heat therapyincludes delivering heat to the patient's first eye from each one of thefirst plurality of heat sources simultaneously.

In some embodiments, the present invention provides a method forapplying stimulation therapy to a patient, wherein the patient has afirst eye and a second eye, and wherein the first eye and the second eyeeach include an upper eyelid and a lower eyelid, the method includingproviding a first stimulation strip that includes a first elongatedportion and a second elongated portion, and wherein the firststimulation strip includes a first plurality of individually controlledelectrodes, a first plurality of individually controlled heat sources,and a first plurality of individually controlled light emitters; placingthe first elongated portion of the first stimulation strip on the uppereyelid of the first eye of the patient; placing the second elongatedportion of the first stimulation strip on the lower eyelid of the firsteye of the patient; delivering a microcurrent stimulation therapy to thepatient's first eye via the first plurality of individually controlledelectrodes; delivering a heat therapy to the patient's first eye via thefirst plurality of individually controlled light heat sources; anddelivering a light-stimulation therapy to the patient's first eye viathe first plurality of individually controlled light emitters.

In some embodiments, the method further includes: providing a secondstimulation strip that includes a first elongated portion and a secondelongated portion, and wherein the second stimulation strip includes asecond plurality of individually controlled electrodes, a secondplurality of individually controlled heat sources, and a secondplurality of light emitters; placing the first elongated portion of thesecond stimulation strip on the upper eyelid of the second eye of thepatient; placing the second elongated portion of the second stimulationstrip on the lower eyelid of the second eye of the patient; delivering amicrocurrent stimulation therapy to the patient's second eye via thesecond plurality of individually controlled electrodes; delivering aheat therapy to the patient's second eye via the second plurality ofindividually controlled heat sources; and delivering a light-stimulationtherapy to the patient's second eye via the second plurality ofindividually controlled light emitters. In some embodiments, thedelivering of the microcurrent stimulation therapy to the patient'ssecond eye occurs simultaneously with the delivering of the microcurrentstimulation therapy to the patient's first eye.

It is to be understood that the above description is intended to beillustrative, and not restrictive. Although numerous characteristics andadvantages of various embodiments as described herein have been setforth in the foregoing description, together with details of thestructure and function of various embodiments, many other embodimentsand changes to details will be apparent to those of skill in the artupon reviewing the above description. The scope of the invention shouldbe, therefore, determined with reference to the appended claims, alongwith the full scope of equivalents to which such claims are entitled. Inthe appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein,” respectively. Moreover, the terms “first,” “second,” and“third,” etc., are used merely as labels, and are not intended to imposenumerical requirements on their objects.

What is claimed is:
 1. A method for applying stimulation therapy to apatient, the method comprising: providing a first stimulation strip,wherein the first stimulation strip includes a first plurality ofindividually controlled electrodes and one or more individuallycontrolled light emitters; placing the first stimulation strip on atleast one of an upper eyelid and a lower eyelid of a first eye of thepatient; delivering a first microcurrent stimulation therapy to thefirst eye of the patient via the first plurality of individuallycontrolled electrodes; and delivering a first light-stimulation therapyto the first eye of the patient via the one or more individuallycontrolled light emitters, wherein the delivering of thelight-stimulation therapy includes delivering infrared optical signalsconfigured to trigger nerve-action potentials (NAPs) in neural tissue ofthe first eye of the patient.
 2. The method of claim 1, wherein eachrespective electrode of the first plurality of electrodes contacts thepatient at a respective contact pressure, the method further comprising:selectively maintaining the respective contact pressure of eachrespective electrode at a value in a range of two (2) ounces per squareinch (0.862 kilopascals) to fifteen (15) pounds per square inch (103.4kilopascals).
 3. The method of claim 1, wherein the delivering of thefirst microcurrent stimulation therapy occurs simultaneously with thedelivering of the first light-stimulation therapy.
 4. The method ofclaim 1, further comprising: providing a stimulator configured togenerate the microcurrent stimulation therapy delivered by the firstplurality of individually controlled electrodes; operatively couplingthe stimulator to the first plurality of individually controlledelectrodes; and placing the stimulator on the patient.
 5. The method ofclaim 1, further comprising: providing a stimulator configured togenerate the microcurrent stimulation therapy delivered by the firstplurality of individually controlled electrodes; operatively couplingthe stimulator to the first plurality of individually controlledelectrodes; and placing the stimulator in a location separate from thepatient.
 6. The method of claim 1, further comprising generating anindicative sound to indicate a characteristic of the first microcurrentstimulation therapy.
 7. The method of claim 1, further comprising:providing a second stimulation strip, wherein the second stimulationstrip includes a second plurality of individually controlled electrodesand one or more individually controlled light emitters; placing thesecond stimulation strip on at least one of an upper eyelid and a lowereyelid of a second eye of the patient; delivering a second microcurrentstimulation therapy to the second eye of the patient via the secondplurality of individually controlled electrodes; and delivering a secondlight-stimulation therapy to the second eye of the patient via the oneor more individually controlled light emitters, wherein the deliveringof the second light-stimulation therapy includes delivering infraredoptical signals configured to trigger nerve-action potentials (NAPs) inneural tissue of the second eye of the patient.
 8. The method of claim7, wherein the delivering of the first microcurrent stimulation therapyto the first eye occurs simultaneously with the delivering of the secondmicrocurrent stimulation therapy to the second eye.
 9. The method ofclaim 1, wherein the delivering of the first microcurrent stimulationtherapy includes setting a stimulation level of the first microcurrentstimulation therapy based on a tolerance of the patient, wherein thesetting of the stimulation level includes: increasing an intensity ofthe first microcurrent stimulation therapy at a rate that allows thepatient to respond to discomfort until the patient provides feedbackindicating that the first microcurrent stimulation therapy has reached apatient-indicated discomfort threshold, and decreasing the intensity ofthe microcurrent stimulation therapy until the patient provides feedbackindicating that the microcurrent stimulation therapy is below thediscomfort threshold, wherein the level of the first microcurrentstimulation therapy is set at the intensity that brings the patientbelow the discomfort threshold.
 10. A system for application of astimulation therapy to a patient, the system comprising: a firststimulation strip configured to be placed on at least one of an uppereyelid and a lower eyelid of a first eye of the patient, wherein thefirst stimulation strip includes: a first plurality of individuallycontrolled electrodes, wherein the first plurality of individuallycontrolled electrodes is configured to deliver microcurrent stimulationtherapy to the first eye of the patient, and one or more individuallycontrolled light emitters, wherein the one or more individuallycontrolled light emitters are configured to deliver light-stimulationtherapy to the first eye of the patient, wherein the light-stimulationtherapy includes infrared optical signals that are configured to triggernerve-action potentials (NAPs) in neural tissue of the first eye of thepatient; and a controller operatively coupled to the first stimulationstrip and configured to control delivery of the microcurrent stimulationtherapy and the light stimulation therapy to the first eye of thepatient.
 11. The system of claim 10, wherein each respective electrodeof the first plurality of electrodes contacts the patient at arespective contact pressure, the system further comprising: apressure-control device coupled to the first strip and configured toselectively maintain the respective contact pressure of each respectiveelectrode.
 12. The system of claim 10, wherein the controller isconfigured to control the first plurality of electrodes and the one ormore light emitters such that the microcurrent stimulation therapy isdelivered during a first time period and the light-stimulation therapyis delivered during a second time period that follows the first timeperiod.
 13. The system of claim 10, wherein the first plurality ofelectrodes is part of a disposable electrode-strip housing that includesa respective gelled contact point for each respective one of the firstplurality of electrodes, and wherein the housing includes a peel-offcover that is removed to expose each respective gelled contact point.14. The system of claim 10, further comprising a stimulator operativelycoupled to the first plurality of individually controlled electrodes andconfigured to generate the microcurrent stimulation therapy delivered bythe first plurality of individually controlled electrodes, wherein thestimulator is placed on the patient.
 15. The system of claim 10, furthercomprising an audio-output unit configured to provide an indicativesound to indicate a characteristic of the microcurrent stimulationtherapy.
 16. The system of claim 10, further comprising: a secondstimulation strip configured to be placed on at least one of an uppereyelid and a lower eyelid of a second eye of the patient, wherein thesecond stimulation strip includes: a second plurality of individuallycontrolled electrodes, wherein the second plurality of individuallycontrolled electrodes is configured to deliver microcurrent stimulationtherapy to the second eye of the patient, and one or more individuallycontrolled light emitters, wherein the one or more individuallycontrolled light emitters are configured to deliver light-stimulationtherapy to the second eye of the patient; wherein the controller isoperatively coupled to the second stimulation strip and the controlleris further configured to control delivery of the microcurrentstimulation therapy and the light stimulation therapy to the second eyeof the patient.
 17. The system of claim 16, wherein at least oneselected from the group consisting of the microcurrent stimulationtherapy and the light-stimulation therapy is delivered to the first eyeof the patient and the second eye of the patient simultaneously.
 18. Thesystem of claim 10, wherein the light-stimulation therapy is deliveredas a plurality of light pulses.
 19. The system of claim 10, furthercomprising: a trans-cranial magnetic pulse (TCMP) generator configuredto generate a magnetic pulse focused on a selected region of the firsteye of the patient.
 20. A system for application of a stimulationtherapy to a patient, the system comprising: a first stimulation strip,wherein the first stimulation strip includes: means for delivering afirst microcurrent stimulation therapy to a first eye of the patient,wherein the means for delivering the first microcurrent stimulationtherapy contacts the patient at a contact pressure, and means fordelivering a first infrared-light stimulation therapy to the first eyeof the patient, wherein the first infrared-light stimulation therapytriggers nerve-action potentials (NAPs) in neural tissue of the firsteye of the patient; means for selectively maintaining the contactpressure of the means for delivering the first microcurrent stimulationtherapy; and means for controlling the means for delivering the firstmicrocurrent stimulation therapy and the means for delivering the firstinfrared-light stimulation therapy.